MAHURKAR 8813817009Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10884521004917), received between Jul 28, 2017 and Apr 25, 2024 — classified as 1 injury, 72 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (26 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE INSERTION OF THE CATHETER, THE INTRODUCER NEEDLE WAS ALREADY PUNCTURED, AND A GUIDEWIRE WAS INSERTED INTO THE PATIENT. WHEN TRYING TO INSERT THE GUIDEWIRE THROUGH THE CATHETER, AT THAT TIME, THE GUIDEWIRE DID NOT PASS THROUGH THE CATHETER, AND THERE WAS SOME BLOCKAGE INSIDE IT. FLUSHING OF THE CATHETER WAS DONE WHEN THE GUIDEWIRE DID NOT PASS THROUGH THE CATHETER, AND IT WAS FOUND THAT THERE WAS SOME BLOCKAGE THAT SUPPRESSED THE FLOW. NOTHING UNUSUAL WAS OBSERVED IN THE PRODUCT PRIOR TO USE. THEY DID NOT USE OTHER DEVICE WITH THE CATHETER KIT. THERE WAS NO OTHER DAMAGE PRESENT ON THE CATHETER OR ANY OTHER COMPONENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. NO TEGO WAS UTILIZED. LUER ADAPTERS WERE NOT USED. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. THE DOCTOR TOOK BACK THE CATHETER AND USED ANOTHER ACUTE DUAL LUMEN CATHETER KIT ON THE SAME DAY WITH THE SAME PRODUCT ID (IDENTIFIER) AND THE SAME LOT, WHICH WAS FROM THE CO MPANY THEY HAD KEPT IN THEIR INVENTORY, AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE DONE ONLY WAS THE EXCHANGE OF ANOTHER CATHETER. NO INTERVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182314 ↗
• MalfunctionJan 23, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE GUIDEWIRE WAS NOT GOING INSIDE THE CATHETER THROUGH BOTH SIDES (ARTERIAL LUMEN AND VENOUS LUMEN). THE GUIDE WIRE WAS STUCK. NO EXCESSIVE FORCE WAS APPLIED TO THE PRODUCT. THE GUIDE WIRE DID NOT BREAK INTO PIECES. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO CATHETER-DIMENSION ISSUE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. FLUSHING WAS NORMAL. THE CATHETER WAS NOT OCCLUDED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING AGENT WAS USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THE GUIDE WIRE WAS NOT FRAYED, COILED, UNRAVELED, ETC. THE GUIDEWIRE WAS SAME WHICH WAS GIVEN IN KIT. THE CATHETER WAS NOT USED AND WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563784 ↗
• MalfunctionAug 8, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE ATTENDING THE PROCEDURE THE CLINICIAN IDENTIFIED THE 1ST REPORTED GUIDEWIRE WAS NOT PASSING THROUGH THE INTRODUCER NEEDLE. THEN ON THE 2ND MENTIONED PRODUCT (2 QUANTITY) WHILE INSERTING, THE CLINICIAN IDENTIFIED THAT THE TIP OF THE CATHETER WAS OCCLUDED, AND THE TYPE OF OCCLUSION THAT WAS OBSERVED WAS THAT THE GUIDEWIRE WAS NOT PASSING. THEN ON THE 3RD PRODUCT WHILE TRYING TO DO THE PROCEDURE, THE CLINICIAN FOUND THAT THE CATHETER LUMEN WAS BLOCKED AND THE TYPE OF BLOCKAGE THAT WAS OBSERVED WAS THAT THE GUIDEWIRE WAS NOT PASSING. THE GUIDEWIRE WAS NOT PASSING THROUGH THE LUMEN. THEN ON THE 4TH PRODUCT WHILE TRYING TO DO INSERTION, IT WAS FOUND THAT THE GUIDEWIRE WAS NOT PASSING THROUGH THE INTRODUCER NEEDLE. THE GUIDEWIRE WAS GETTING STUCK UP IN THE NEEDLE. THE ISSUE ON ALL PRODUCTS MENTIONED OBSERVED ON THE SAME EVENT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE ON ALL PRODUCTS. THE CLEANING AGENT USED ON ALL DEVICES WAS CHLOROHEXIDINE. TEGO WAS NOT UTILIZED IN ALL PRODUCTS. THE CATHETER WAS NOT REPAIRED IN ALL PRODUCTS. THE GUIDE WIRE WAS NOT FRAYED, COILED OR UNRAVELED. NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481659 ↗
• MalfunctionAug 8, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE ATTENDING THE PROCEDURE THE CLINICIAN IDENTIFIED THE 1ST REPORTED GUIDEWIRE WAS NOT PASSING THROUGH THE INTRODUCER NEEDLE. THEN ON THE 2ND MENTIONED PRODUCT (2 QUANTITY) WHILE INSERTING, THE CLINICIAN IDENTIFIED THAT THE TIP OF THE CATHETER WAS OCCLUDED, AND THE TYPE OF OCCLUSION THAT WAS OBSERVED WAS THAT THE GUIDEWIRE WAS NOT PASSING. THEN ON THE 3RD PRODUCT WHILE TRYING TO DO THE PROCEDURE, THE CLINICIAN FOUND THAT THE CATHETER LUMEN WAS BLOCKED AND THE TYPE OF BLOCKAGE THAT WAS OBSERVED WAS THAT THE GUIDEWIRE WAS NOT PASSING. THE GUIDEWIRE WAS NOT PASSING THROUGH THE LUMEN. THEN ON THE 4TH PRODUCT WHILE TRYING TO DO INSERTION, IT WAS FOUND THAT THE GUIDEWIRE WAS NOT PASSING THROUGH THE INTRODUCER NEEDLE. THE GUIDEWIRE WAS GETTING STUCK UP IN THE NEEDLE. THE ISSUE ON ALL PRODUCTS MENTIONED OBSERVED ON THE SAME EVENT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE ON ALL PRODUCTS. THE CLEANING AGENT USED ON ALL DEVICES WAS CHLOROHEXIDINE. TEGO WAS NOT UTILIZED IN ALL PRODUCTS. THE CATHETER WAS NOT REPAIRED IN ALL PRODUCTS. THE GUIDE WIRE WAS NOT FRAYED, COILED OR UNRAVELED. NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481609 ↗
• MalfunctionMay 30, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, RIGHT AFTER CATHETER IMPLANTATION, THERE WAS NO BLOOD FLOW OBSERVED FROM THE VENOUS EXTENSION TUBE (BLUE PORT) OF THE CATHETER BUT WHEN THE DEVICE WAS FLUSHED PRIOR TO USE/INSERTION IT HAD A NORMAL OUTCOME. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO DAMAGE NOTED ON THE PRODUCT AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CUSTOMER TRIED TO REVERSE THE LINE. THE OCCLUSION WAS NOT DUE TO THROMBOSIS. THE CATHETER WAS EXCHANGED FROM THE HOSPITAL INTERNAL STOCK. THE CATHETER WAS REPLACED WITH A NEW DEVICE TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022332 ↗
• MalfunctionApr 3, 2023Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE WHILE PULLING OUT THE GUIDE WIRE, IT GOT KINKED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE WITH NORMAL RESULT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER DAMAGES NOTED ON THE PRODUCT ASIDE FROM BEING KINKED. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. IT WAS MENTIONED THAT IT WAS NECESSARY TO REMOVE THEGUIDE WIRE AND CATHETER SIMULTANEOUSLY IN ONE ACTION DUE TO ALLEGED DEFECT. THERE WAS NO OCCLUSION AND GUIDE WIRE WAS STILL INTACT WHEN IT WAS REMOVED. THERE WAS NO EXCESSIVE FORCE USED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. THE GUIDE WIRE WITH CATHETER WAS REMOVED TO RESOLVE THE ISSUE AND THERE WERE NO TOOLS USED TO REMOVE IT. PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS OF ABOUT 5ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668365 ↗
• MalfunctionFeb 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CATHETER IMPLANTATION, BLOOD LEAK WAS NOTED FROM THE BLUE PORT OF THE LUER ADAPTER DESPITE APPLYING THE LOCK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED AND THE ADAPTERS WAS TIGHTEN BY HAND. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED AND THE INSERTION WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO LUER ADAPTER ISSUE, POVIDONE IODINE WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE CATHETER WAS REPLACED AS THE INTERVENTION/TREATMENT AS THE RESULT OF THE EVENT AND THE PROCEDURE WAS COMPLETED AFTER THE DEVICE WAS REPLACED. THERE WAS A BLOOD LOSS OF 5 ML (MILLILITER) AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300901 ↗
• MalfunctionFeb 2, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE CATHETER TIP WAS TILTED WHEN THE DOCTOR OPENED THE PACKAGE; IT WAS NOT INSERTED. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE, AND 70% ISOPROPYL ALCOHOL WAS USED AS A CLEANING AGENT ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS PASS. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO DAMAGE TO THE PACKAGE. THERE WERE NO VISIBLE DEFECTS OR DAMAGE FOUND ON THE PRODUCT DURING VISUAL INSPECTION. THE PRODUCT WAS REPLACED WITH THE SAME LOT ON THE SAME DAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283819 ↗
• MalfunctionJan 13, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDEWIRE GOT STUCK IN BETWEEN THE NEEDLE AND NEEDLE HUB. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO LUER ADAPTER ISSUE. THE GUIDEWIRE HAD NO FLAWS OR DAMAGES, SUCH AS FRAYING, COILING, OR UNRAVELING. THE GUIDEWIRE WAS PROVIDED WITH THE KIT. FLUSHING THE INTRODUCER NEEDLE PRIOR TO USE PRODUCED NORMAL RESULTS WITH NO OCCLUSION. NO EXCESSIVE FORCE WAS USED DURING INSERTION OR REMOVAL. IT WAS ALSO MENTIONED THAT RESISTANCE HAD BEEN NOTED. THERE WERE NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE INTRODUCER NEEDLE AND GUIDE WIRE WERE NOT REMOVED SIMULTANEOUSLY FROM THE PATIENT (THE GUIDEWIRE WAS REMOVED). ALL GUIDEWIRE PIECES ARE PRESENT AND CORRECT, WITH NO BROKEN PIECES. THERE WAS NO DIMENSION ISSUE NOTED, AND BOTH THE DIMENSION OF THE NEEDLE AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT NEEDED. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT DUE TO THE EVENT. A NEW CATHETER WAS PULLED OUT AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163836 ↗
• MalfunctionJan 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CATHETER IMPLANTATION, IT WAS NOTED THAT THERE WAS BLOOD LEAKAGE FROM THE EXIT SITE OF THE BLUE PORT DESPITE APPLYING THE LOCK AND A CRACK WAS FOUND IN IT. THE CATHETER WAS NOT REPAIRED. POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE AND ALSO USED TO CLEAN THE ADAPTERS. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULT. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE ADAPTERS WERE USUALLY TIGHTENED BY HAND AND CLEANING AGENT WAS DRIED THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. A NEW CATHETER WAS IMPLANTED TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS OF ABOUT 10 ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163604 ↗
• MalfunctionDec 21, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING TEST FLOW BEFORE INSERTION, IT WAS FOUND BY THE HCP (HEALTHCARE PROFESSIONAL) THAT THE CATHETER TIP (SHAFT) WAS OBSTRUCTED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE DEVICE WAS REPLACED AS REMEDIAL ACTION, SUCCESSFULLY USED AND COMPLETED THE PROCEDURE. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028252 ↗
• MalfunctionOct 18, 2022Break; Product Quality Problem; Difficult to Remove; Obstruction of Flow; Break; Product Quality Problem; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN THE HEALTHCARE PROFESSIONAL WAS TESTING OUT IF THE GUIDE WIRE CAN BE INSERTED INTO THE CATHETER AND WHEN TRYING TO FLUSH THE DEVICE/TESTING OUT THE FLOW BEFORE INSERTION, THE GUIDE WIRE WAS STUCK INSIDE THE CATHETER AND IT WAS NOTED THAT THE SHAFT HAD A HOLE NEAR THE TIP (LOWER PART). IT WAS ALSO STATED THAT THERE WAS AN OCCLUSION AT THE TIP OF THE CATHETER (CATHETER TIP WAS OBSTRUCTED). THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO OTHER DAMAGES/DEFECT FOUND ON THE PRODUCT, PACKAGING AND STERILE BARRIER ASIDE FROM THE HOLE. THERE WAS NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. EXCESSIVE FORCE WAS USED WHEN TRYING TO INSERT THE GUIDE WIRE AND WHEN FLUSHING THE DEVICE. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE CATHETER MAT CHED WITH WHAT WAS INDICATED N THE LABEL. THE PRODUCT WAS REPLACED WITH A NEW ONE AND WITH SAME SIZE AND LENGTH TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626400 ↗
• MalfunctionOct 4, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO OPERATION, WHEN THEY TESTED THE CATHETER, IT CAN BE FLUSHED WITH NORMAL SALINE BUT IT WAS OCCLUDED. BY OCCLUDED, THEY MEANT THE GUIDE WIRE COULD NOT BE INSERTED THROUGH CATHETER VEIN SIDE. THEY INSERTED THE GUIDE WIRE FROM THE TIP FIRST BUT IT WAS OBSTRUCTED THEN THEY INSERTED IT AGAIN FROM CAP SIDE AND IT WAS STILL OBSTRUCTED. THERE WAS ALSO A LITTLE BIT HARDER TO PUSH THEM BEFORE THEY GOT OBSTRUCTED. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES IN FLUSHING, SHE FLUSHED FROM THE CAP SIDE ONLY. THE GUIDE WIRE WAS NEW AND IN GOOD CONDITION. THE GUIDE WIRE NOT FRAYED, COILED, UNRAVELED. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AS IT WAS IN GOOD CONDITION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. 70% ISOPROPYL ALCOHOL WAS THE CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE DOCTOR CHANGED THE PRODUCT WITH NEW/REPLACEMENT CATHETER SET (SAME LOT) FOR HER PATIENT ON THE SAME DATE AS THE EVENT DATE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537093 ↗
• MalfunctionOct 4, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO OPERATION, WHEN THEY TESTED THE CATHETER, IT CAN BE FLUSHED WITH NORMAL SALINE BUT IT WAS OCCLUDED. BY OCCLUDED, THEY MEANT THE GUIDE WIRE COULD NOT BE INSERTED THROUGH CATHETER VEIN SIDE. THEY INSERTED THE GUIDE WIRE FROM THE TIP FIRST BUT IT WAS OBSTRUCTED THEN THEY INSERTED IT AGAIN FROM CAP SIDE AND IT WAS STILL OBSTRUCTED. THERE WAS ALSO A LITTLE BIT HARDER TO PUSH THEM BEFORE THEY GOT OBSTRUCTED. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES IN FLUSHING, SHE FLUSHED FROM THE CAP SIDE ONLY. THE GUIDE WIRE WAS NEW AND IN GOOD CONDITION. THE GUIDE WIRE NOT FRAYED, COILED, UNRAVELED. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AS IT WAS IN GOOD CONDITION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. 70% ISOPROPIL ALCOHOL WAS THE CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE DOCTOR CHANGED THE PRODUCT WITH NEW/REPLACEMENT CATHETER SET (SAME LOT) FOR HER PATIENT ON THE SAME DATE AS THE EVENT DATE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537013 ↗
• MalfunctionJul 18, 2022Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, ON THE DAY OF PROCEDURE, DURING PRE-OPERATIVE AND FLUSHING, WHEN THE CATHETER WAS NOT YET IMPLANTED TO THE PATIENT, SOME OBSTRUCTION WAS NOTED IN THE RED/ARTERIAL LUMEN. THE CATHETER WAS NOT REPAIRED, NO LEAK, NO TEGO UTILIZED, THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT, AND NO LUER ADAPTER ISSUE. NO CLEANING AGENT USED ON THE DEVICE. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO PROBLEM WITH THE CATHETER'S DIMENSION. THE DIMENSION OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL. THE OCCLUSION WAS NOT DUE TO THROMBOSIS. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. CATHETER WAS KEPT SEPARATELY ON THE SURGICAL TROLLEY. NEW CATHETER WITH SIMILAR MODEL NUMBER, SAME LOT WAS OPENED ON THE SAME DAY AND FLUSHING WAS DONE SUCCESSFULLY IN CATHETER FROM THE NEW KIT. CATHETER FROM NEW KIT WAS SUCCESSFULLY IMPLANTED AS INTERVENTION AND PATIENT COMPLETED DIALYSIS SESSION DURING POST PROCEDURE. THERE WAS NO BLOOD LOSS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042378 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDEWIRE WAS BLOCKED/STUCK AT THE TIP INTRODUCER NEEDLE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO LUER ADAPTER ISSUE. NO DEFECT/DAMAGES WERE NOTED ON THE GUIDEWIRE, LIKE FRAYED, COILED OR UNRAVEL. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED AND THE DOCTOR USED THE ITEM AVAILABLE WITHIN THE PACK. PRIOR TO USE, FLUSHING OF INTRODUCER NEEDLE WITH NORMAL SALINE WAS DONE. NO EXCESSIVE FORCE WAS USED DURING INSERTION/REMOVAL. IT WAS SAID THAT WHILE PULLING BACK, THERE WAS A RESISTANCE NOTED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THE DOCTOR PULLED BACK THE NEEDLE ALONG WITH THE GUIDEWIRE (THE INTRODUCER NEEDLE AND GUIDE WIRE WERE REMOVED SIMULTANEOUSLY FROM THE PATIENT). TO RESOLVE THE ISSUE, THE DOCTOR USED ANOTHER CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982247 ↗
• MalfunctionMay 31, 2022Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE RETRIEVING THE GUIDE WIRE FROM THE NEEDLE, IT GOT KINKED AND BECAME DIFFICULT TO TAKE IT OUT (IT WAS STUCK). NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE (PACKAGING WAS DISCARDED ONCE OPENED). THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. CHLOROHEXIDINE SOLUTION 2% WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. NO DAMAGE WAS NOTED ON THE GUIDEWIRE LIKE FRAYED, COILED, UNRAVEL AND HAD NO BROKEN PIECES. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. NO DIMENSION ISSUE WAS NOTED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. FLUSHING WAS DONE AND THERE WAS NO ISSUE WITH THE CATHETER. NO EXCESSIVE FORCE WAS USED DURING INSERTION/REMOVAL BUT THERE WAS A RESISTANCE NOTED DURING WITHDRAWAL. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. IT WAS SAID THAT THE GUIDEWIRE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE NEEDLE BUT THEY STILL MANAGED AND SUCCEEDED TO TAKE OUT THE GUIDEWIRE AS IT CAME OUT AFTER MANY ATTEMPTS OF WITHDRAWAL. PROCEDURE WAS SAID TO BE NOT COMPLETED. THERE WAS NO REPORTED PATIENT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550358 ↗
• MalfunctionFeb 10, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDEWIRE WAS STUCK AT THE HUB WHILE INSIDE THE CATHETER AND DID NOT COME OUT/PASS THROUGH OF THE VENOUS LINE OF ULTEM ADAPTER (BLUE COLOR) DUE TO SOME BLOCKAGE SO THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER. THE CATHETER WAS NEVER IMPLANTED IN THE PATIENT AS THE GUIDEWIRE DID NOT COME OUT OF THE VENOUS LINE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. CHLOROHEXIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE AND NOTHING ABNORMAL WAS FOUND AND NO OCCLUSION WAS NOTED. THE DIMENSIONS OF THE CATHETER AND THE GUIDEWIRE MATCHED WITH WHAT WAS INDICATED ON THE LABEL AND NO DIMENSION ISSUE WAS NOTED. NO EXCESSIVE FORCE WAS USED DURING INSERTION/REMOVAL AND NO RESISTANCE WAS NOTED WHEN INSERTING THE GUIDEWIRE. NO TOOLS WERE USED WHEN TRYING TO REMOVE THE GUIDEWIRE. THE GUIDEWIRE WAS STILL INTACT WHEN REMOVED AND ALL PIECES OF THE GUIDEWIRE WERE ACCOUNTED FOR (NO BROKEN PIECES). THERE WAS A FEW ML OF BLOOD LOSS (HCP DID NOT MENTION THE QUANTITY)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507195 ↗
• InjuryNov 2, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2021 AND (B)(6) 2021, THE PATIENT HAD CATHETER PLACEMENTS. IT WAS SAID THAT ON (B)(6) 2021, DURING USE OF BOTH CATHETERS, CATHETER-RELATED BLOODSTREAM INFECTION (CRBSI) OCCURRED. THE CATHETERS WERE NOT REPAIRED AND HAD NO LEAK. IODOPOVIDONE WAS THE CLEANING AGENT USED FOR BOTH DEVICES. TEGO WAS NOT UTILIZED. THERE WERE NO LUER ADAPTER ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 12737760 ↗
• MalfunctionOct 10, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDEWIRE PROVIDED IN THE KIT WAS STUCK INSIDE THE CATHETER AT THE HUB AND DID NOT COME OUT OF THE VENOUS LINE ULTEM ADAPTER (BLUE COLOR). THEY ALSO STATED THAT THE HEALTHCARE PROFESSIONAL MENTIONED THAT THE GUIDEWIRE WAS STUCK BECAUSE THE CATHETER HAD SOME BLOCKAGE IN THE HUB. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE AND NOTHING ABNORMAL WAS FOUND, THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO TREATMENT/INTERVENTION REQUIRED AS A RESULT OF THE EVENT. THE GUIDEWIRE WAS REMOVED THROUGH THE HANDS, NO TOOLS WAS USED WHEN TRYING TO REMOVE IT AND IT WAS NECESSARY TO REMOVE THE GUIDEWIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. IT WAS STATED THAT THE GUIDEWIRE WAS STILL INTACT WHEN THEY REMOVED IT AND TO RESOLVE THE ISSUE A FRESH PACK OF THE CATHETER WAS OPENED AND USED, AND THE PROCEDURE WAS COMPLETED. X-RAY WAS NOT REQUIRED. THERE WAS A FEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602664 ↗
• MalfunctionAug 12, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, BEFORE INSERTING CATHETER ON THE PATIENT, THEY TRIED TO FLUSH WITH NS (NORMAL SALINE) AND IT WAS FOUND THAT THE ARTERIAL LUMEN WAS BLOCKED. THEY ALSO TRIED WITH A GUIDE WIRE AND THE GUIDE WIRE WAS NOT PASSING. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFUL AND COMPLETED WITH ANOTHER CATHETER KIT (FROM THEIR STOCK). THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION. THE DIMENSION OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ASIDE FROM REPORTED ISSUE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO SOLUTION OR AGENT WAS USED ON THE INSERTION SITE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312780 ↗
• MalfunctionJul 28, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS SESSION, LEAKAGE WAS OBSERVED AND ON DISCONNECTION A CRACK WAS NOTED ON THE RED (ARTERIAL) LUER ADAPTER. DIALYSIS WAS STOPPED AND A NEW CATHETER WAS INSERTED AS AN INTERVENTION. TREATMENT WAS COMPLETED SUCCESSFULLY. THERE WAS A BLOOD LOSS OF APPROXIMATELY 5 ML, BUT NO BLOOD TRANSFUSION REQUIRED. FLUSHING WAS DONE SUCCESSFULLY PRIOR TO USE. THE CATHETER WAS NOT REPAIRED AND NO TEGO UTILIZED. CHLORHEXIDINE WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. BETADINE WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NO INSTRUMENT BUT ONLY HAND WAS USED TO LOOSEN OR TIGHTEN THE ADAPTERS. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239241 ↗
• MalfunctionApr 6, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING PROCEDURE/INSERTION PROCESS, WHEN THEY INSERTED THE CATHETER, THE GUIDEWIRE CAN'T PASS THROUGH THE CATHETER. IT WAS SAID THAT FLUSHING WAS DONE PRIOR TO USE AND OCCLUSION WAS NOTED AND DURING VISUAL INSPECTION, CLOT WAS NOTED. THE REPORTED CATHETER WAS REPAIRED BUT OPENING A NEW PRODUCT (ANOTHER ONE WAS PULLED OUT) WAS DONE TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO LEAK. HEPALINE WAS THE CLEANING AGENT(S) USED ON THE DEVICE. ANTISEPTIC SOLUTION WAS THE CLEANING AGENT USED TO CLEAN/TREAT THE INSERTION SITE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL OBSERVED PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE DIMENSION(S) OF THE CATHETER AND THE GUIDEWIRE MATCHED WITH WHAT WAS INDICATED ON THE LABEL. THE CATHETER AND THE GUIDEWIRE WERE PART OF THE KIT BEING USED. NO EXCESSIVE FORCE APPLIED. ALL PIECES WERE ACCOUNTED FOR. NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617327 ↗
• MalfunctionFeb 15, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, AFTER FLUSHING WAS DONE SUCCESSFULLY DURING THE CATHETER INSERTION PROCEDURE, THE GUIDE WIRE WAS NOT PASSING THROUGH THE ARTERIAL LUMEN OF THE FIRST CATHETER. THE FAULTY CATHETER AND GUIDEWIRE WERE REMOVED AND DISCARDED. IT WAS MENTIONED THAT IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. WHEN THE GUIDE WIRE WAS REMOVED, IT WAS OBSERVED THAT THE GUIDE WIRE WAS STILL INTACT AND WAS COILED. WHEN THE OTHER 4 CATHETERS IN THE BOX WERE CHECKED FOR THE SAME EVENT AND PATIENT, SIMILAR ISSUE OF GUIDE WIRE NOT PASSING THROUGH THE LUMEN WAS NOTED WHEN THEY TRIED TO USE THE OTHER 4 CATHETERS TO THE PATIENT. THE CATHETERS WERE NOT REPAIRED AND THERE WAS NO LEAK. BETADINE AND CHLORHEXIDINE WAS USED AS CLEANING AGENTS ON THE DEVICES. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. BETADINE WAS ALSO USED AS A CLEANING AGENT ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO DAMAGE TO THE DEVICES' BOX AND PACKAGING. THERE WAS NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE PRODUCTS AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICES PRIOR TO USE. NO OTHER PRODUCTS WERE BEIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327306 ↗
• MalfunctionDec 2, 2020Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO USE (AFTER PACKAGE OPENING AND SUBSEQUENT FLUSHING WITH NORMAL SALINE), IT WAS STATED THAT THE DEVICES ARTERIAL LUMEN WAS FOUND TO BE OCCLUDED (DAMAGE), THERE WERE NO DAMAGE ON THE PRODUCT AND PACKAGING UPON RECEIPT, THE LINES WAS NOT REVERSED. ANOTHER KIT WAS OPENED BUT WAS STATED TO HAVE THE SAME ISSUE. THERE WAS NO OTHER PARTS OF DEVICE MISSING, THE KIT WAS SEALED UPON RECEIPT, THERE WAS NO PACKAGING DAMAGE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936622 ↗