MAHURKAR 8813793009Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10884521004801), received between Mar 14, 2017 and Jul 23, 2025 — classified as 3 deaths, 9 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN FLUSHING, IT WAS FOUND THAT THE CATHETER HAD A WATER LEAKAGE FROM THE IV (INTRAVENOUS) CONNECTOR SILICONE TUBING (EXIT SITE) NEAR LUER ADAPTER. IT WAS ALSO STATED THAT THERE WAS A SMALL HOLE IN THE IV CONNECTOR SILICONE TUBING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE ASIDE FROM THE ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH A NEW CATHETER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583493 ↗
• MalfunctionJul 16, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE GUIDEWIRE HAD MEMORY LOSS DURING THE FIRST PASSAGE, WITH FOLDS AND ANGLES THAT IMPEDE AND HINDER THE PROGRESSION OF THE CATHETER AND INCREASE THE RISK OF LOCAL PUNCTURE COMPLICATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523391 ↗
• MalfunctionJul 14, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY PUNCTURE PROCEDURE, THE GUIDEWIRE BROKE, MAKING IT IMPOSSIBLE TO INSERT THE CATHETER. THE GUIDEWIRE HAD MEMORY LOSS DURING THE FIRST PASSAGE, WITH FOLDS AND ANGLES THAT IMPEDE AND HINDER THE PROGRESSION OF THE CATHETER AND INCREASE THE RISK OF LOCAL PUNCTURE COMPLICATIONS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22494450 ↗
• MalfunctionMay 28, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY PUNCTURE PROCEDURE, THE GUIDE WIRE GOT BROKEN, MAKING IT IMPOSSIBLE FOR THE CATHETER TO BE INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096867 ↗
• MalfunctionNov 26, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE GUIDEWIRE GOT STUCK WHEN THE GUIDEWIRE WAS WITHDRAWN AFTER PUNCTURE AND COULD NOT BE USED NORMALLY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS OR DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. EXCESSIVE FORCE WAS USED ON THE DEVICE. NO CLEANING AGENT(S) WAS USED ON THE DEVICE. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. GUIDEWIRE WAS STILL INTACT AFTER IT WAS MANUALLY REMOVED. AS A REMEDIAL ACTION, THE PUNCTURE NEEDLE IN THE CENTRAL VENOUS CATHETER KIT WAS THEN USED TO GUIDE THE CATHETER; THE CATHETER WAS SUCCESSFULLY PLACED AND PROCEEDED AND COMPLETED THE PROCEDURE. INTERVENTION OR TREATMENT WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784519 ↗
• MalfunctionNov 15, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AFTER PUNCTURE, WHEN THE GUIDEWIRE WAS WITHDRAWN, THE GUIDEWIRE GOT STUCK AND COULD NOT BE USED NORMALLY. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THE GUIDEWIRE PROVIDED WITH WAS THE KIT BEING USED. THE GUIDEWIRE WAS REMOVED MANUALLY AND STILL INTACT. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE CATHETER WAS THEN GUIDED USING THE PUNCTURE NEEDLE IN THE CENTRAL VENOUS CATHETER PACK AND THE CATHETER PLACEMENT WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695781 ↗
• MalfunctionNov 12, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DYSPNEA FOR MORE THAN 3 HOURS. AFTER ADMISSION, THE PATIENT WAS MAINLY DIAGNOSED WITH ACUTE HEART FAILURE, CHRONIC KIDNEY DISEASE STAGE 5, ETC., SO TEMPORARY HEMODIALYSIS CATHETER PLACEMENT IN THE RIGHT FEMORAL VEIN WAS PERFORMED UNDER LOCAL ANESTHESIA AT THE BEDSIDE IN THE NEPHROLOGY WARD. AFTER THE OPERATION, BEDSIDE HEMODIALYSIS TREATMENT WAS PERFORMED, AND DUE TO WORSENING HEART FAILURE AND ACUTE RESPIRATORY FAILURE, THE PATIENT WAS TRANSFERRED TO THE DEPARTMENT OF CRITICAL CARE MEDICINE ON THE SAME DAY. THE PATIENT WAS TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT) FOR CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) TREATMENT TO REMOVE EXCESS TOXINS AND WATER IN THE BODY AND MAINTAIN THE STABILITY OF THE INTERNAL ENVIRONMENT. ON THE MORNING OF SEPTEMBER 30, 2024, THE PATIENT'S HEMODIALYSIS MACHINE ALARMED THAT THE VENOUS PRESSURE WAS HIGH AND THE HEMODIALYSIS PROCESS WAS NOT SMOOTH, AND THE PATIENT GOT OFF THE MACHINE. AFTER THE NURSE CHECKED, A RUPTURE WAS FOUND AT THE VENOUS END INTERFACE (BLUE VENOUS EXTENSION TUBE) OF THE TEMPORARY HEMODIALYSIS CATHETER IN THE RIGHT F EMORAL VEIN, AND THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669033 ↗
• DeathOct 4, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED SEVERE HEMORRHAGIC SHOCK AFTER PUNCTURE OF A DOUBLE LUMEN (D/L) HEMODIALYSIS CATHETER IN THE COMMON FEMORAL ARTERY AND SUPERFICIAL ON THE LEFT, ASSOCIATED WITH BREAKAGE OF THE GUIDE DURING PUNCTURE. THE PATIENT DIED. BASED ON AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE WHETHER OR NOT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH.

  Patient problems: Hypovolemic Shock

  MAUDE report 20369813 ↗
• MalfunctionMay 15, 2024Product Quality Problem; Difficult to Remove; Unraveled Material; Product Quality Problem; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING SURGERY, THE GUIDE WIRE WAS KINKED AND WAS STUCK CLOSE TO THE "J" SHAPE. THE GUIDE WIRE WAS COILED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO TOOLS WERE USED TO REMOVE THE GUIDE WIRE. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. THE GUIDE WIRE DID NOT BREAK INTO PIECES. THE GUIDE WIRE USED WAS THE ONE INCLUDED IN THE KIT. THE DIMENSION(S) OF THE CATHETER AND THE GUIDE WIRE MATCHED WHAT WAS INDICATED ON THE LABEL. THERE WAS NO DIMENSION ISSUE NOTED. THE DEVICE WAS OBSERVED AS NORMAL PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH SALINE AND IT HAD NO PROBLEM. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS WAS BEING UTILIZED WITH THE DEVICE. THEY REMOVED THE GUIDE WIRE AS A REMEDIAL ACTION PERFORMED TO ADDRESS THE ISSUE. IT WAS NECESSARY TO REMOVE THE GUIDE WIRE TOGETHER (AT THE SAME TIME) WITH CATHETER OR PUNCTURE NEEDLE (FROM WHERE IT WAS INSERTED). THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO INTERVENTION/TREAT MENT REQUIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321613 ↗
• MalfunctionMay 3, 2024Break; Difficult to Advance; Break; Difficult to Advance

  ACCORDING TO THE REPORTER, DURING PROCEDURE/INSERTION, THE GUIDEWIRE DID NOT PROGRESS/PASS INTO THE CATHETER. NOTHING UNUSUAL AND NO DAMAGED OBSERVED ON THE CATHETER AND GUIDEWIRE BEFORE/PRIOR TO USE. NO DAMAGE NOTED ON THE DEVICE PACKAGING. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE DURING THE PROCEDURE. INSERTION SITE WAS TREATED WITH ALCOHOLIC CHLORHEXIDINE BEFORE PRODUCT PLACEMENT. THE GUIDEWIRE AND THE CATHETER WERE PROVIDED WITH THE KIT BEING USED. THE DIMENSION(S) OF THE CATHETER AND THE GUIDEWIRE MATCHED WITH WHAT WAS INDICATED ON THE LABEL. NO DIMENSION ISSUE WAS NOTED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS A RESISTANCE NOTED BUT NO EXCESSIVE FORCE WAS USED DURING INSERTION/REMOVAL. ALL PIECES OF THE GUIDEWIRE WERE ACCOUNTED FOR. NO CATHETER OCCLUSION WAS NOTED. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. NO MEDICAL INTERVENTIO N/TREATMENT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236225 ↗
• MalfunctionFeb 6, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) HEMODIALYSIS TREATMENT WAS PERFORMED ON THE PATIENT AT THE FACILITY. A BEDSIDE DEEP VENIPUNCTURE OF THE RIGHT FEMORAL VEIN WAS PERFORMED TO PLACE A TEMPORARY HEMODIALYSIS TUBE IN THE RIGHT FEMORAL VEIN. DURING THE PUNCTURE PROCESS, AFTER THE VENOUS BLOOD WAS SUCCESSFULLY WITHDRAWN, A GUIDE WIRE WAS INSERTED INTO THE PUNCTURE NEEDLE TUBE, THE GUIDE WIRE WAS FIXED, AND THE PUNCTURE NEEDLE WAS WITHDRAWN AT THE SAME TIME. THE SKIN EXPANSION TUBE (BLUE DILATOR) WAS INSERTED ALONG THE GUIDE WIRE, AND THE SKIN WAS EXPANDED, BUT IT WAS NOT SMOOTHLY WITHDRAWN. AFTER WITHDRAWAL, IT WAS FOUND THAT THE GUIDE WIRE WAS BENT, AND THE TIP OF THE SKIN EXPANSION TUBE WAS BROKEN, ON WHICH THERE WAS A CRACKED TIP. IT WAS ALSO STATED THERE WAS A POSSIBLE RISK OF FOREIGN MATTER RESIDUE. THERE WAS NO LEAK. THE EXPANSION TUBE WAS NOT SEPARATED INTO TWO OR MORE MULTIPLE PIECES. ASIDE FROM BENT, THERE WAS NO OTHER ISSUE OBSERVED ON THE GUIDEWIRE. THE GUIDEWIRE AND DILATOR WERE USED THAT WERE INCLUDED ON THE KIT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT ASID

  Patient problems: Insufficient Information

  MAUDE report 18652647 ↗
• MalfunctionFeb 5, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GUIDE WIRE WAS STUCK IN PUNCTURE NEEDLE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18641413 ↗
• MalfunctionNov 30, 2023Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THEY RECEIVED FEEDBACK FROM THE HOSPITAL THAT DURING THE PROCESS OF PASSING THROUGH THE GUIDE WIRE, THE CATHETER HAD COMPLETELY FAILED TO PASS THROUGH THE GUIDE WIRE, BECAME STUCK AND THE GUIDE WIRE WAS BENT. EVEN IF IT WAS BARELY SUCCESSFULLY IMPLANTED, THE FLOW PERFORMANCE DURING SUBSEQUENT USE WAS POOR AND COULD NOT MEET TREATMENT NEEDS. AFTER REPEATED COMMUNICATION, THE CUSTOMER STILL SAID THAT THE DIFFICULTY OF USING THIS PRODUCT BROUGHT GREAT INCONVENIENCE AND RISK TO THE SURGERY AND THE USE EFFECT AFTER IMPLANTATION WAS ALSO POOR. THE HOSPITAL ALSO BELIEVED THAT THE PRODUCT WAS DEFECTIVE IN MANUFACTURING AND THE PROBABILITY OF PROBLEMS IS EXTREMELY HIGH AND SO THEY REFUSED TO CONTINUE USING THIS MODEL OF PRODUCT AND REQUIRED THE RETURN OF ALL 11.5FR (FRENCH) ACUTE CATHETER PRODUCTS. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18237281 ↗
• MalfunctionNov 30, 2023Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THEY RECEIVED FEEDBACK FROM THE HOSPITAL THAT DURING THE PROCESS OF PASSING THROUGH THE GUIDE WIRE, THE CATHETER HAD COMPLETELY FAILED TO PASS THROUGH THE GUIDE WIRE, BECAME STUCK AND THE GUIDE WIRE WAS BENT. EVEN IF IT WAS BARELY SUCCESSFULLY IMPLANTED, THE FLOW PERFORMANCE DURING SUBSEQUENT USE WAS POOR AND COULD NOT MEET TREATMENT NEEDS. AFTER REPEATED COMMUNICATION, THE CUSTOMER STILL SAID THAT THE DIFFICULTY OF USING THIS PRODUCT BROUGHT GREAT INCONVENIENCE AND RISK TO THE SURGERY AND THE USE EFFECT AFTER IMPLANTATION WAS ALSO POOR. THE HOSPITAL ALSO BELIEVED THAT THE PRODUCT WAS DEFECTIVE IN MANUFACTURING AND THE PROBABILITY OF PROBLEMS IS EXTREMELY HIGH AND SO THEY REFUSED TO CONTINUE USING THIS MODEL OF PRODUCT AND REQUIRED THE RETURN OF ALL 11.5FR (FRENCH) ACUTE CATHETER PRODUCTS. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18237083 ↗
• MalfunctionNov 28, 2023Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THEY RECEIVED A FEEDBACK FROM THE HOSPITAL THAT DURING THE PROCESS OF PASSING THROUGH THE GUIDE WIRE, THE CATHETER HAD COMPLETELY FAILED TO PASS THROUGH THE GUIDE WIRE, BECAME STUCK AND THE GUIDE WIRE WAS BENT. EVEN IF IT WAS BARELY SUCCESSFULLY IMPLANTED, THE FLOW PERFORMANCE DURING SUBSEQUENT USE WAS POOR AND COULD NOT MEET TREATMENT NEEDS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18221814 ↗
• MalfunctionNov 28, 2023Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Product Quality Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THEY RECEIVED A FEEDBACK FROM THE HOSPITAL THAT DURING THE PROCESS OF PASSING THROUGH THE GUIDE WIRE, THE CATHETER HAD COMPLETELY FAILED TO PASS THROUGH THE GUIDE WIRE, BECAME STUCK AND THE GUIDE WIRE WAS BENT. EVEN IF IT WAS BARELY SUCCESSFULLY IMPLANTED, THE FLOW PERFORMANCE DURING SUBSEQUENT USE WAS POOR AND COULD NOT MEET TREATMENT NEEDS. AFTER REPEATED COMMUNICATION, THE CUSTOMER STILL SAID THAT THE DIFFICULTY OF USING THIS PRODUCT BROUGHT GREAT INCONVENIENCE AND RISK TO THE SURGERY AND THE USE EFFECT AFTER IMPLANTATION WAS ALSO POOR, SO THEY REFUSED TO CONTINUE USING IT AND THEY ASKED TO RETURN IT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18221620 ↗
• MalfunctionNov 7, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, LAPAROTOMY WAS THE PATIENT'S INITIAL DIAGNOSIS AND THE CATHETER PUNCTURE WAS PERFORMED AFTER THE PATIENT'S SURGERY, DUE TO THE CLINICAL NEED FOR HEMODIALYSIS. DURING THE INTRODUCTION OF THE GUIDE WIRE INTO THE PUNCTURE NEEDLE OF THE DIALYSIS CATHETER, IT DID NOT PROGRESS AND STUCK INSIDE THE NEEDLE. IT HAD LOOSENED ITS COATING AND RELEASING ITS SPRINGS. THERE WAS AN ATTEMPT TO CUT THE GUIDE WIRE TO REUSE THE KIT, BUT IT WAS NOT POSSIBLE. THERE WAS NO LEAK. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. TO IMPLANT THE DEVICE, THE SKIN WAS CLEANED WITH DEGERMING AND ALCOHOLIC CHLORHEXIDINE. THE GUIDEWIRE WAS REMOVED ACCORDING TO THE MEDICAL TECHNIQUE USED, AFTER INSERTION OF THE CATHETER. THERE WAS NO EXCESSIVE FORCE USED ON THE PRODUCT. THE GUIDE WIRE SHOWED RESISTANCE AND WAS NO LONGER INTACT, IT RELEASED THE SPRINGS (UNSCREWING). THE GUIDE WIRE PASSED CORRECTLY AND SUCCESSFUL AFTER REQUESTING A NEW KIT. AS A REMEDIAL ACTION, ANOTHER STROKE KIT (ANOTHER BRAND AND SUPPLIER) WAS REQUESTED TO COMPLETE THE PROCEDURE. THE ISSUE WAS RESOLVED, AND PROCEDURE WAS COMPLETED BY USING A PRODU

  Patient problems: Insufficient Information; Liver Damage/Dysfunction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082480 ↗
• MalfunctionNov 6, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IN PLACE INTO THE PATIENT FOR 4 MONTHS AT THE TIME OF THE EVENT. THE PATIENT WAS UN DERGOING HEMODIALYSIS IN A MEDICAL INSTITUTION. DURING THE DIALYSIS PROCESS, THE NURSE DISCOVERED THAT THE VENOUS (BLUE) EXTENSION TUBE NEAR THE LUER ADAPTER/EXTENSION FITTING (BLOOD RETURN END) OF THE HEMODIALYSIS CATHETER WAS LEAKING BLOOD DURING INSPECTION. IT WAS STATED THAT THE HEMODIALYSIS WAS EXPECTED TO REMOVE INFLAMMATORY MEDIATORS AND TO MAINTAIN INTERNAL ENVIRONMENT STABILITY. THERE WERE NO COMBINED MEDICATION/DEVICE. IT WAS MENTIONED THAT THERE WAS NO EXTERNAL FACTOR, BUT BLOOD LEAKAGE OCCURRED DURING THE PROCESS. FLUSHING WAS DONE PRIOR TO USE WITH PRE-FILLED NORMAL SALINE AND THE RESULT WAS NORMAL. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE AND TO THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. IT WAS SUSPECTED THAT THE PRODUCT QUALITY INSPECTION WAS NOT STRICT. IN ORDER TO AVOID INFECTION AND OTHER SITUATIONS, AS A PRELIMINARY ACTION, THE CENTRAL VENOUS CATHETER AND ACC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081055 ↗
• MalfunctionNov 3, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN IMPLANTED IN THE PATIENT FOR 67 HOURS. WHEN HEMODIALYSIS WAS BEING PERFORMED IN THE PATIENT, THE PHYSICIAN FOUND THAT BLOOD WAS LEAKING FROM THE VENOUS EXTENSION TUBE NEAR THE LUER ADAPTER (BACK/RETURN END) OF THE H EMODIALYSIS CATHETER. A COMPETITOR'S MACHINE WAS USED. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. FLUSHING WAS DONE PRIOR TO USE AND HAD A NORMAL OUTCOME. HEMODIALYSIS WAS IMMEDIATELY ENDED, THE DEFECTIVE CATHETER WAS REMOVED/EXPLANTED AND PLACED A NEW CATHETER AGAIN ON THE SAME DAY TO CONTINUE HEMODIALYSIS AND TO RESOLVE THE ISSUE. TREATMENT WAS COMPLETED. IT WAS ALSO MENTIONED THAT THERE WAS A POSSIBILITY THAT THE CATHETER MIGHT BECAME LOOSE DURING USE. THERE WAS BLOOD LOSS OF ABOUT 200ML 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 18067175 ↗
• MalfunctionOct 18, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER INSERTED INTO THE RIGHT INTERNAL VEIN BY AN EXPERIENCED ANAESTHESIOLOGIST HAD COMPLETELY BROKEN THREE TIMES, AND IT REQUIRED REMOVAL. IT WAS ALSO STATED THAT THE J-GUIDE WIRE WAS TOO THIN FOR A RIGID DILATOR. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE DURATION OF THE IMPLANTATION WAS ONE HOUR. THE REPLACEMENT OF THE PUNCTURE WAS THE REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT. PATIENT OUTCOME WAS EXPOSURE TO HEMORRHAGE AND THE EFFECTS OF RE-PUNCTURE EACH TIME.

  Patient problems: Insufficient Information

  MAUDE report 17961959 ↗
• MalfunctionOct 18, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER INSERTED INTO THE RIGHT INTERNAL VEIN BY AN EXPERIENCED ANAESTHESIOLOGIST HAD COMPLETELY BROKEN THREE TIMES, AND IT REQUIRED REMOVAL. IT WAS ALSO STATED THAT THE J-GUIDE WIRE WAS TOO THIN FOR A RIGID DILATOR. THE DURATION OF THE IMPLANTATION WAS ONE HOUR. THE REPLACEMENT OF THE PUNCTURE WAS THE REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT. PATIENT OUTCOME WAS EXPOSURE TO HEMORRHAGE AND THE EFFECTS OF RE-PUNCTURE EACH TIME.

  Patient problems: Insufficient Information

  MAUDE report 17961902 ↗
• MalfunctionOct 18, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER INSERTED INTO THE RIGHT INTERNAL VEIN BY AN EXPERIENCED ANAESTHESIOLOGIST HAD COMPLETELY BROKEN THREE TIMES, AND IT REQUIRED REMOVAL. IT WAS ALSO STATED THAT THE J-GUIDE WIRE WAS TOO THIN FOR A RIGID DILATOR. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE DURATION OF THE IMPLANTATION WAS ONE HOUR. THE REPLACEMENT OF THE PUNCTURE WAS THE REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT. PATIENT OUTCOME WAS EXPOSURE TO HEMORRHAGE AND THE EFFECTS OF RE-PUNCTURE EACH TIME.

  Patient problems: Insufficient Information

  MAUDE report 17961397 ↗
• MalfunctionOct 18, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER INSERTED INTO THE RIGHT INTERNAL VEIN BY AN EXPERIENCED ANAESTHESIOLOGIST HAD COMPLETELY BROKEN THREE TIMES, AND IT REQUIRED REMOVAL. IT WAS ALSO STATED THAT THE J-GUIDE WIRE WAS TOO THIN FOR A RIGID DILATOR. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE DURATION OF THE IMPLANTATION WAS ONE HOUR. THE REPLACEMENT OF THE PUNCTURE WAS THE REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT. PATIENT OUTCOME WAS EXPOSURE TO HEMORRHAGE AND THE EFFECTS OF RE-PUNCTURE EACH TIME.

  Patient problems: Insufficient Information

  MAUDE report 17961354 ↗
• MalfunctionOct 18, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER INSERTED INTO THE RIGHT INTERNAL VEIN BY AN EXPERIENCED ANAESTHESIOLOGIST HAD COMPLETELY BROKEN THREE TIMES, AND IT REQUIRED REMOVAL. IT WAS ALSO STATED THAT THE J-GUIDE WIRE WAS TOO THIN FOR A RIGID DILATOR. THE DURATION OF THE IMPLANTATION WAS ONE HOUR. THE REPLACEMENT OF THE PUNCTURE WAS THE REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT. PATIENT OUTCOME WAS EXPOSURE TO HEMORRHAGE AND THE EFFECTS OF RE-PUNCTURE EACH TIME.

  Patient problems: Insufficient Information

  MAUDE report 17961213 ↗
• MalfunctionOct 18, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE CATHETER INSERTED INTO THE RIGHT INTERNAL VEIN BY AN EXPERIENCED ANAESTHESIOLOGIST HAD COMPLETELY BROKEN THREE TIMES, AND IT REQUIRED REMOVAL. IT WAS ALSO STATED THAT THE J-GUIDE WIRE WAS TOO THIN FOR A RIGID DILATOR. THE DURATION OF THE IMPLANTATION WAS ONE HOUR. THE REPLACEMENT OF THE PUNCTURE WAS THE REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT. PATIENT OUTCOME WAS EXPOSURE TO HEMORRHAGE AND THE EFFECTS OF RE-PUNCTURE EACH TIME.

  Patient problems: Insufficient Information

  MAUDE report 17961034 ↗