MAHURKAR 8830415001Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884521005150), received between Nov 10, 2017 and Aug 8, 2025 — classified as 2 deaths, 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (8 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, A LEAKAGE WAS FOUND AT THE SILICONE IV CONNECTOR, FROM THE VENOUS SITE OF THE CATHETER (JUNCTION OF EXTENSION TUBE AND BIFURCATE) BEFORE SURGERY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, IT WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22752172 ↗
• MalfunctionApr 16, 2024Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT IN THE HOSPITAL, THE DOCTOR REPORTED THAT THE CATHETER WAS INSTALLED 24 HOURS AGO, BUT WHEN THE PATIENT TRIED TO REMOVE IT, THE WINGLETS WERE BROKEN IT DETACHED FROM THE CATHETER, WHICH MEANT THAT THE SECUREMENT WINGS OF THE CATHETER WERE BROKEN BUT THE FIXING POINTS REMAINED ON THE SKIN (THE CATHETER DID NOT MOVE OUT OF PLACE). THE TREATMENT WAS NOT COMPLETED. THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. THE RING OF THE SUTURE WING DID NOT BREAK. THE CATHETER WAS REMOVED AS A REMEDIAL ACTION TO RESOLVE THE ISSUE. THE PRODUCT WAS NOT REPLACED. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION OR MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117587 ↗
• MalfunctionFeb 7, 2024Insufficient Flow or Under Infusion; Connection Problem; Insufficient Flow or Under Infusion; Connection Problem

  ACCORDING TO THE REPORTER, WHEN THE HEMODIALYSIS WAS PERFORMED, THE CATHETER HAD LOW RETURN AND FLOW, AND THE LUMENS DID NOT CONNECT CORRECTLY IN THE HEMODIALYSIS SYSTEM. IN ADDITION TO NOT CORRECTLY PULLING THE BLOOD FLOW, EVEN THE PATHWAYS WERE REVERSED, THERE WAS NO PROGRESS IN THE PROCEDURE, AND DUE TO MALFUNCTION, THE SYSTEM CLOTTED MORE THAN ONCE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18664519 ↗
• MalfunctionFeb 7, 2024Insufficient Flow or Under Infusion; Connection Problem; Insufficient Flow or Under Infusion; Connection Problem

  ACCORDING TO THE REPORTER, WHEN THE HEMODIALYSIS WAS PERFORMED, THE CATHETER HAD LOW RETURN AND FLOW, AND THE LUMENS DID NOT CONNECT CORRECTLY IN THE HEMODIALYSIS SYSTEM. IN ADDITION TO NOT CORRECTLY PULLING THE BLOOD FLOW, EVEN THE PATHWAYS WERE REVERSED, THERE WAS NO PROGRESS IN THE PROCEDURE, AND DUE TO MALFUNCTION, THE SYSTEM CLOTTED MORE THAN ONCE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18664297 ↗
• MalfunctionDec 19, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ACCORDING TO THE REPORTER, DURING IMPLANT PROCEDURE, THERE WAS A PROBLEM WITH THE TIP AND EXTENSION OF THE CATHETER. WHEN REMOVING THE CATHETER, IT WAS IDENTIFIED THAT THE CATHETER TIP (AT THE SHAFT PART) WAS BENT/KINKED. THE BLUE EXTENSION TUBE WAS DETACHED FROM THE HUB. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE THERE WAS NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. IT WAS STATED THAT AS A MEDICAL INTERVENTION/TREATMENT, AN EXCHANGE WAS CARRIED OUT BUT WITHOUT SUCCESS AND THE VASCULAR SURGERY WAS CALLED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359486 ↗
• MalfunctionDec 13, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE CATHETER MALFUNCTIONED. WHEN IT TRIED TO DIALYZE, IT DID NOT GIVE A GOOD FLOW OF BLOOD. IT WAS ALSO STATED THAT THERE WAS AN OBSTRUCTION ON THE PRODUCT. THERE WAS OCCLUSION DUE TO THROMBOSIS AND THE TUBE OF THE CATHETER WAS THE PART THAT WAS OCCLUDED. FINALLY, THEY PLACED A COMPETITIVE CATHETER AND THAT WORKED WELL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322648 ↗
• MalfunctionAug 21, 2023Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POSTOPERATIVE, THE CATHETER MALFUNCTIONED WITHIN HOURS OF BEING INSTALLED. WHEN IT TRIED TO DIALYZE, IT DID NOT GIVE A GOOD FLOW OF BLOOD. IT WAS ALSO STATED THAT THERE WAS AN OBSTRUCTION ON THE PRODUCT. THERE WAS OCCLUSION DUE TO THROMBOSIS AND THE TUBE OF THE CATHETER WAS THE PART THAT WAS OCCLUDED. FLUSHING WAS PERFORMED WITHOUT PROBLEM PRIOR TO INSERTION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NO LEAK, AND THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE INSERTION SITE WAS TREATED WITH PRIOR TO PRODUCT PLACEMENT. ALCOHOL WAS USED AS CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. THERE WERE NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER HAD ONLY BEEN IN PLACE NOT MORE THAN 2 DAYS. SUBSEQUENTLY, IT WAS CHANGED FOR ANOTHER OF OUR CATHETERS OF THE SAME SIZE, AND IT MALFUNCTIONED JUST THE SAME. FINALLY, THEY PLACED AND CHANGED THE PRODUCT TO A COMPETITIVE CATHETER AS THE REMEDIAL ACTION AND AS THE INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17590200 ↗
• MalfunctionAug 18, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, POSTOPERATIVE, THE CATHETER MALFUNCTIONED WITHIN HOURS OF BEING INSTALLED. WHEN IT TRIED TO DIALYZE, IT DID NOT GIVE A GOOD FLOW OF BLOOD. IT WAS ALSO STATED THAT THERE WAS AN OBSTRUCTION ON THE PRODUCT. THERE WAS OCCLUSION DUE TO THROMBOSIS AND THE TUBE OF THE CATHETER WAS THE PART THAT WAS OCCLUDED. FLUSHING WAS PERFORMED WITHOUT PROBLEM PRIOR TO INSERTION. THE CATHETER WAS NOT REPAIRED. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NO LEAK, AND THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE INSERTION SITE WAS TREATED WITH PRIOR TO PRODUCT PLACEMENT. ALCOHOL WAS USED AS CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. THERE WERE NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER HAD ONLY BEEN IN PLACE NOT MORE THAN 2 DAYS. SUBSEQUENTLY, IT WAS CHANGED FOR ANOTHER OF OUR CATHETERS OF THE SAME SIZE, AND IT MALFUNCTIONED JUST THE SAME. FINALLY, THEY PLACED AND CHANGED THE PRODUCT TO A COMPETITIVE CATHETER AS THE REMEDIAL ACTION AND AS THE INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577126 ↗
• MalfunctionJun 29, 2023Product Quality Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Product Quality Problem; Insufficient Flow or Under Infusion; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE GUIDE WIRE HAS NO ROOM OR SPACE FOR PROGRESS DUE TO POOR MANUAL PROGRESSION, AND THE ENTIRE GUIDE WIRE NEEDS TO BE EXTERNALIZED. EVEN WITH LOW BLOOD FLOW (200 ML/MIN), THE CATHETER WAS CONSTANTLY COLLAPSING, AND THE EFFECTIVENESS OF DIALYSIS WAS COMPROMISED,  FREQUENCY OF SESSIONS WAS INCREASED AND HIGH DOSES OF HEPARIN WAS USED. FREQUENT CHANGE OF CATHETER AND LINES WAS NEEDED. COAGULATION OF THE SYSTEM WITH BLOOD LOSS AND EVEN THE NEED FOR HEMOTRANSFUSION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17230595 ↗
• MalfunctionJun 1, 2023Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDE WIRE DID NOT PASS THROUGH THE CATHETER. IT WAS ALSO STATED THAT THE SHEATH DID NOT ADVANCE. THERE WAS NO REPORTED PATIENT OUTCOME. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP WAS DAMAGED, BENT, OR DISCONNECTED FROM THE CATHETER AS A RESULT OF A MANUFACTURING ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17043710 ↗
• MalfunctionMay 11, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHILE THE CUSTOMER WAS INSERTING THE SHORT-TERM CATHETER, IT WAS NOTICED THAT THE TIP OF CATHETER, AT THE JUNCTION OF THE EXTENSION TUBE AND RED (ARTERIAL) LUER ADAPTER WAS LEAKING WHILE THEY WERE TRYING TO FLUSH IT. THE CATHETER WAS FLUSHED WITH A CLEAR SOLUTION USING A SYRINGE (RED SIDE) AND WHEN ASPIRATED, BLOOD CAN BE SEEN WITH BUBBLES INSIDE THE SYRINGE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE CLEANING AGENT USED ON THE DEVICE WAS CLOROHEXIDEN GLUCONATE. THE CLEANING AGENT UTILIZED TO CLEAN THE ADAPTER WAS CHLOROHEXIDINE GLUCONATE WITH ALCOHOL 70%. AS PER CUSTOMER IT WAS A REGULAR ROUTINE PROCEDURE AND THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION THE CATHETER WAS DISCARDED AND REPLACED BY ANOTHER CATHETER FROM A DIFFERENT BRAND/MANUFACTURER. IT WAS STATED THAT THERE WAS NO STOCK IN THE HOSPITAL FROM COVIDIEN. THE PROCEDURE WAS COMPLETED USING THE OTHER PRODUCT FROM A DIFFERENT BRAND. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916082 ↗
• MalfunctionApr 28, 2023Product Quality Problem; Obstruction of Flow; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A DIFFICULT PASSAGE AND GUIDE WIRE DID NOT HAVE A ROLLER FOR PROGRESSING IT, MAKING THE MOST DIFFICULT CATHETER PASSAGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16837384 ↗
• MalfunctionDec 1, 2022Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE SILICONE CATHETER HAD LEAKAGE. IT WAS STATED THAT THERE WAS A LEAK AT THE CATHETER SHAFT AND VENOUS EXTENSION TUBE. THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS REPAIRED AND WAS REMOVED ON THE SAME DAY OF THE EVENT. IODINE VOLTS (IODOPHOR) WAS THE CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895749 ↗
• MalfunctionNov 15, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS STUCK IN THE CATHETER WHEN IT WAS ALREADY IN THE PATIENT'S VEIN. THERE WAS NO LUER ADAPTER ISSUE AND THE PATIENT HAD HEMATOMA AS THE SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hematoma

  MAUDE report 15798809 ↗
• MalfunctionSep 1, 2022Obstruction of Flow; Material Deformation; Migration; Obstruction of Flow; Material Deformation; Migration

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER CONSTANTLY COLLAPSED. THE CATHETER WAS REPAIRED. IT WAS SAID THAT THE CATHETER HAD NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336594 ↗
• MalfunctionDec 23, 2021Pumping Problem; Pumping Problem

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS TREATMENT, THE CATHETER WAS TORN IN RED PATHWAY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 13076101 ↗
• MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, AFTER THE CATHETER WAS PUT IN, IT WAS FOUND TO OOZE BLOOD NEAR THE BEGINNING OF THE Y. FLUSHING WAS DONE PRIOR TO USE AND THERE WAS NO PROBLEM. THE CATHETER WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE LEAKAGE. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS BUT NO BLOOD TRANSFUSION REQUIRED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE PATIENT THEMSELVES WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON THE CATHETER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS A PACKAGING DAMAGED. 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 11735998 ↗
• MalfunctionApr 5, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT HAD CDL (DOUBLE LUMEN CATHETER) STRAIGHT EXTENSIONS PERFORMED IN THE RIGHT JUGULAR WITH VASCULAR. IT WAS MENTIONED THAT THE CATHETER STAYED WITH THE CLIENT FOR 14 DAYS AND WHILE USING IT, FLUSHING WAS DONE AND THE VENOUS LUMEN (EXTENSION TUBE) HAD A FISSURE AT THE JUNCTION OF EXTENSION TUBE AND THE VENOUS LUER ADAPTER AND WHEN JETTING/APPLYING WITH THE 10 ML SYRINGE, IT HAD LEAKAGE THROUGH THE FISSURE. THE PRODUCT WAS IMMEDIATELY REMOVED FROM THE PATIENT SO AS NOT TO RUN THE RISK OF CONTAMINATION. THERE WAS NO DAMAGE TO THE DEVICE'S PACKAGING AND THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS BLOOD LOSS BUT THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THEY HAD TO USE ANOTHER PRODUCT TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613579 ↗
• MalfunctionJan 15, 2021Defective Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE AND POST IMPLANT, THE CATHETER WAS PLIABLE AND WRINKLED. IT WAS ALSO STATED THAT THE CATHETER WAS NOT FULLY IMPLANTED CAUSING THE BENDING AT THE CATHETER SHAFT AND THE PREVENTING FLOW ISSUE. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT LEAD TO OR EXTEND THE PATIENT HOSPITALIZATION. A NEW CATHETER WAS USED TO RESOLVED THE ISSUE AND AS THE INTERVENTION/SURGERY TO PREVENT DAMAGE TO THE PATIENT. IT WAS ALSO STATED THAT THERE WAS A CONSTANT TRAUMA IN THE NEW PUNCTURE AND IN ADDITION TO EXPOSING THE PATIENT TO THE RISKS INHERENT IN MULTIPLE CATHETER PUNCTURES. IT WAS ALSO MENTIONED THAT THERE WAS NO CLEANING AGENT USED ON THE DEVICE, THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS, BLOOD TRANSFUSION WAS NOT REQUIRED, THE DEVICE WAS NOT SUCCESSFULLY USED, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED WITH POSITIVE RESULT AND THERE WAS NO DIFFICULTY IN RINSING THE CATHETER'S TUBE WITH SYRINGE. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11176535 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, THE GUIDE WIRE DISCONNECTED IN THE "PUNCH CANNULA". THERE WAS BLEEDING AT THE APPLICATION SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778000 ↗
• MalfunctionSep 18, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, THE GUIDE WIRE WAS STUCK IN THE NEEDLE AND CANNOT BE PULLED OUT. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. NORMAL SALINE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. NOTHINGUNUSUAL OBSERVED PRIOR TO USE. NO PACKAGE DAMAGE. NO DEFECTS/DAMAGES FOUND ON THE NEEDLE AND THE GUIDEWIRE. THE GUIDEWIRE AND NEEDLE WERE PART OF THE KIT USED. THE DIMENSIONS OF THE GUIDEWIRE AND NEEDLE MATCHED ON THE PACKAGE LABEL. THE NEEDLE WAS FLUSHED PRIOR TO USE WITH A SMOOTH RESULTS AND NO OCCLUSION NOTED. NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE GUIDE WIRE. WHEN REMOVED WITH REGULAR UNLOADING, THE GUIDEWIRE WAS STILL INTACT AND ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO X-RAY WAS DONE. NO BLOOD TRANSFUSION WAS DONE. NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. ANOTHER ONE WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE/SURGERY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10552471 ↗
• MalfunctionSep 2, 2020Difficult to Advance; Infusion or Flow Problem; Difficult to Advance; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THERE WAS IMPLANTATION PROBLEM WITH DIFFICULTY IN PASSING THE GUIDE WIRE AND IT WAS NECESSARY TO USE MORE THAN ONE CATHETER FOR THE SAME IMPLANT. AFTER IMPLANTATION, THERE WAS LOW FLOW AND CATHETER DYSFUNCTION. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND IT DID NOT LEAD TO EXTENDED PATIENT HOSPITALIZATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Unintended Radiation Exposure

  MAUDE report 10483491 ↗
• MalfunctionFeb 18, 2020Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, THE GUIDE WIRE WAS NOTED TO BE BRANCHING AND UNRAVELED AND CANNOT BE PULLED OUT. THE CATHETER WAS FLUSHED PRIOR TO USE AND THE LINES WERE NOT REVERSED. THE DIMENSIONS OF THE CATHETER WAS STATED TO MATCH WHAT WAS INDICATED IN THE LABEL AND THE GUIDE WIRE PROVIDED IN THE KIT WAS THE ONE USED DURING THE INSERTION. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAKAGE. IT WAS ALSO STATED THAT EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE GUIDE WIRE, AND THE GUIDE WIRE AND THE CATHETER WERE REMOVED FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION). THE GUIDE WIRE WAS COMPLETELY REMOVED AND LOCKED IN THE NEEDLE AND WAS NO LONGER INTACT. POST-OPERATIVE X-RAY WAS NOT PERFORMED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE CATHETER WAS REPLACED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720370 ↗
• DeathAug 30, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LARGE BRUISE IMMEDIATELY AFTER PUNCTURING AND RECEIVING THE CATHETER IN THE INTERNAL JUGULAR VEIN. IT WAS ALSO STATED THAT THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. PROTHROMBIN TIME WOULD HAVE RISEN FROM 10 SECONDS TO 72 SECONDS AFTER ADMINISTRATION OF HEPARIN. IT WAS NOTED THAT THE BRUISE WAS ENLARGED OVER TIME, AND THE PATIENT WOULD HAVE CLOTTING DISORDER AND WAS NOT ABLE TO UNDERGO ANY DOSE OF HEPARIN. IT WAS ALSO STATED THAT THE PATIENT HAD THROMBOCYTOPENIA DURING PREVIOUS PUNCTURING IN WHICH THE USE OF HEPARIN WAS SUSPENDED. IT WAS ALSO MENTIONED THAT THE PATIENT WORSENED WHEREIN THERE WAS HEAVY BLEEDING AND DEATH. MEDICAL SAFETY REVIEWED THE EVENT AND DETERMINED THAT IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Blood Loss; Death

  MAUDE report 8950685 ↗
• MalfunctionApr 5, 2019Material Frayed; Difficult to Advance; Material Integrity Problem; Material Frayed; Difficult to Advance; Material Integrity Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE HAD A CRACK ON THE LUER ADAPTER. IT WAS ALSO REPORTED THAT THE GUIDE WIRE HAD AN UNSPECIFIED ISSUE. IT WAS ALSO STATED THAT THE CATHETER WAS REPAIRED, THERE WAS NO LEAK, AND A TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8488319 ↗