MAHURKAR 8831661001Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521005235), received between Jun 19, 2017 and May 31, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING THE FEMORAL DIALYSIS CATHETER, THERE WAS RESISTANCE WHILE DILATING TRACKING WITH THE GUIDEWIRE. THEY STILL DILATED 2 TIMES, BUT WHILE ADVANCING THE CATHETER, THE GUIDEWIRE WAS STUCK. THE PROCEDURE WAS ABANDONED, AND THEY PULLED OUT THE CATHETER AND GUIDEWIRE AS A WHOLE AND NOTED THAT THE GUIDEWIRE WAS KINKED AND UNRAVELED INTRA-LUMINALLY. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS SOFT AND FLIMSY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120342 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING THE FEMORAL DIALYSIS CATHETER, THERE WAS RESISTANCE WHILE DILATING TRACKING WITH THE GUIDEWIRE. THEY STILL DILATED 2 TIMES, BUT WHILE ADVANCING THE CATHETER, THE GUIDEWIRE WAS STUCK. THE PROCEDURE WAS ABANDONED, AND THEY PULLED OUT THE CATHETER AND GUIDEWIRE AS A WHOLE AND NOTED THAT THE GUIDEWIRE WAS KINKED AND UNRAVELED INTRA-LUMINALLY. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS SOFT AND FLIMSY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22097128 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING THE FEMORAL DIALYSIS CATHETER, THERE WAS RESISTANCE WHILE DILATING TRACKING WITH THE GUIDEWIRE. THEY STILL DILATED 2 TIMES, BUT WHILE ADVANCING THE CATHETER, THE GUIDEWIRE WAS STUCK. THE PROCEDURE WAS ABANDONED, AND THEY PULLED OUT THE CATHETER AND GUIDEWIRE AS A WHOLE AND NOTED THAT THE GUIDEWIRE WAS KINKED AND UNRAVELED INTRA-LUMINALLY. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS SOFT AND FLIMSY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22097091 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING THE FEMORAL DIALYSIS CATHETER, THERE WAS RESISTANCE WHILE DILATING TRACKING WITH THE GUIDEWIRE. THEY STILL DILATED 2 TIMES, BUT WHILE ADVANCING THE CATHETER, THE GUIDEWIRE WAS STUCK. THE PROCEDURE WAS ABANDONED, AND THEY PULLED OUT THE CATHETER AND GUIDEWIRE AS A WHOLE AND NOTED THAT THE GUIDEWIRE WAS KINKED AND UNRAVELED INTRA-LUMINALLY. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS SOFT AND FLIMSY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22097063 ↗
• MalfunctionMay 28, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE INSERTING THE FEMORAL DIALYSIS CATHETER, THERE WAS RESISTANCE WHILE DILATING TRACKING WITH THE GUID EWIRE. THEY STILL DILATED 2 TIMES, BUT WHILE ADVANCING THE CATHETER, THE GUIDEWIRE WAS STUCK. THE PROCEDURE WAS ABANDONED, AND THEY PULLED OUT THE CATHETER AND GUIDEWIRE AS A WHOLE AND NOTED THAT THE GUIDEWIRE WAS KINKED AND UNRAVELED INTRA-LUMINALLY. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS SOFT AND FLIMSY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22096964 ↗
• MalfunctionJul 8, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, UPON INITIATION OF THE DIALYSIS SESSION, THE DIALYSIS NURSE FLUSHED THE LINE AND FOUND IT TO BE CRACKED. THEY NOTIFIED THE MICU PROVIDER AND NEPHROLOGY PROVIDER. THE DIALYSIS WAS CONTINUED WITH THE CRACKED LUMEN ACTING AS THE VENOUS ACCESS TO AVOID AIR EMBOLISM. IR (INTERVENTIONAL RADIOLOGY) WAS NOTIFIED AND PLANNED TO REPLACE THE LINE. IT WAS ALSO STATED THAT THE DEFECT WAS AT THE END OF THE CATHETER. DURING ITS FIRST USE, NO ONE WOULD HAVE HAD A REASON TO INTERACT WITH THE LINE BETWEEN ITS PLACEMENT BY IR AND ITS FIRST USE. THEY FLUSHED THE LINE PRIOR TO USE, NOTICED THE LEAK IMMEDIATELY, AND CONTACTED THE COVERING PROVIDER FOR NEPHROLOGY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS A LEAK. THERE WAS AN UNKNOWN AMOUNT OF BLOOD LOSS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19695884 ↗
• 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 18237352 ↗
• MalfunctionNov 29, 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 18229801 ↗
• MalfunctionNov 29, 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 NOTREPAIRED 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 18229684 ↗
• 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, RECEIVED FEEDBACK FROM HOSPITALS THAT THE CATHETER WAS COMPLETELY UNABLE TO PASS THROUGH THE GUIDEWIRE DURING THE COURSE OF PASSING THROUGH THE GUIDEWIRE, AND THE GUIDEWIRE WAS ENTANGLED. EVEN IF THE MEDIUM FLOW RATE DURING SUBSEQUENT USE WAS POOR AFTER BARELY SUCCESSFUL IMPLANTATION, THE TREATMENT NEEDS CANNOT BE MET. RECENTLY, THE SITUATION HAS BECOME MORE FREQUENT. AFTER REPEATED COMMUNICATION, THE CUSTOMER STILL SAID THAT THE DIFFICULTY OF USING THE PRODUCT BROUGHT GREAT INCONVENIENCE AND RISK TO THE SURGERY, AND THE EFFECT OF USING THE PRODUCT AFTER IMPLANTATION WAS POOR, SO THE CUSTOMER REFUSED TO CONTINUE TO USE IT AND ASKED FOR ITS RETURN. THE CATHETER WAS NOT REPAIRED; THERE WAS NO LEAK, 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. THE PRODUCT WAS REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18222124 ↗
• 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, THE CATHETER WAS COMPLETELY UNABLE TO PASS THROUGH THE GUIDEWIRE DURING THE COURSE OF PASSING THROUGH THE GUIDEWIRE, AND THE GUIDEWIRE IS ENTANGLED. EVEN IF THE MEDIUM FLOW RATE DURING THE SUBSEQUENT USE IS POOR AFTER BARELY SUCCESSFUL IMPLANTATION, THE TREATMENT NEEDS CANNOT BE MET. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18222087 ↗
• 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 FEEDBACK FROM THE HOSPITAL THAT WHEN THE CATHETER WAS PASSED THROUGH THE GUIDE WIRE, THE GUIDE WIRE WAS COMPLETELY UNABLE TO PASS, THE GUIDE WIRE BECAME INCARCERATED, AND THE GUIDE WIRE WAS BENT. EVEN IF THE IMPLANTATION WAS BARELY SUCCESSFUL, THE FLOW PERFORMANCE IN SUBSEQUENT USE WAS POOR, WHICH COULD NOT MEET THE TREATMENT NEEDS. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18222001 ↗
• 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 FEEDBACK FROM THE HOSPITAL THAT WHEN THE CATHETER WAS PASSED THROUGH THE GUIDE WIRE, THE GUIDE WIRE WAS COMPLETELY UNABLE TO PASS, THE GUIDE WIRE BECAME INCARCERATED, AND THE GUIDE WIRE WAS BENT. EVEN IF THE IMPLANTATION WAS BARELY SUCCESSFUL, THE FLOW PERFORMANCE IN SUBSEQUENT USE WAS POOR, WHICH COULD NOT MEET THE TREATMENT NEEDS. AFTER REPEATED COMMUNICATION, THE CUSTOMER STILL SAID THAT THE DIFFICULTY OF USING THE PRODUCT BROUGHT GREAT INCONVENIENCE AND RISK TO THE SURGERY, AND THE EFFECT AFTER IMPLANTATION WAS ALSO POOR. THE CUSTOMER REFUSED TO CONTINUE USING IT AND ASKED TO RETURN IT. THE CATHETER WAS NOTREPAIRED; THERE WAS NO LEAK, 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. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18221876 ↗
• MalfunctionAug 22, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS SUCCESSFULLY PLACED INTO THE PATIENT (DEVICE WAS FOR SHORT TERM USE, ACUTE CATHETER) AND SHOULD BE AVAILABLE FOR DAYS. DURING THE PLASMAPHERESIS SESSION AROUND 1 HOUR, A CRACK AND LEAK WAS NOTICED IN THE PROXIMAL PART OF THE VENOUS (BLUE) LUER ADAPTER. THE LEAK WAS LOCATED AT THE DISTAL JUNCTION OF THE LUER ADAPTER BLOCK AND THE TUBING PIECE WHICH SUBSEQUENTLY ENTERED THE CATHETER. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. SOFTASEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE BY USING NORMAL SALINE SOLUTION AND HAD A GOOD RESULT. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. IT WAS MENTIONED THAT THE CATHETER WAS IMMEDIATELY EXPLANTED WHEN THE ISSUE OCCURRED. THE CATHETER WAS REPLACED BY THE SAME BRAND FROM THE SAME CHARGE TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. BLOOD TRANSFUSION WAS NOT REQUIRED. THE FAULTY MEDICAL DEVICE WAS IDENTIFIED IN A TIMELY MANNER SO THERE WAS NO AIR EMBOLISM OR SIGNIFICANT BLOOD LOSS. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597562 ↗
• MalfunctionMar 10, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THERE WAS A PLAN TO PERFORM CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT FOR THE PATIENT. AT 16:00, BEDSIDE CRRT TREATMENT WAS STARTED. THEN AT 17:00, IT WAS FOUND THAT THE VENOUS END (VENOUS EXTENSION NEAR THE ADAPTER) OF THE DOUBLE-LUMEN HEMOFILTRATION TUBE KEPT LEAKING BLOOD. EXAMINATION REVEALED A VERY SMALL BREAK IN THE VENOUS END (VENOUS EXTENSION NEAR THE ADAPTER) OF THE CATHETER. THE BLOOD LEAKAGE WAS OBVIOUS WHEN CRRT TREATMENT WAS PERFORMED. IT WAS TEMPORARY REDUCED AFTER TEMPORARY LOCAL/PARTIAL WRAPPING WITH A TRANSPARENT DRESSING (DRESSING WRAPPED HEMOSTATIC REPAIR MEASURES). IT WAS STATED THAT THE EVENT CAUSE MIGHT BE A PRODUCT QUALITY PROBLEM. THERE WERE NO UNUSUAL OBSERVATIONS (NO ABNORMALITIES) ON THE DEVICE PRIOR TO USE. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS IODINE. THERE WAS NO EXCESSIVE FORCE WAS USED ON THE DEVICE. AS A REMEDIAL ACTION, THE PRODUCT WAS NOT REPLACED BUT WAS REPAIRED. THE PATIENT LEAKED BLOOD (UNKNOWN AMOUNT OF BLOOD LOSS) AND THERE WAS NO BLOOD TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522167 ↗
• MalfunctionJan 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, A CRACK NEAR THE BLUE PART (VENOUS LUER ADAPTER) WAS OBSERVED. THE CATHETER WAS NOT REPAIRED AND THERE WAS A LEAK AT THE LUER ADAPTER. OTHER DEVICE WAS USED AS THE SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16270845 ↗
• MalfunctionJan 12, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT WAS PLANNED TO UNDERGO BEDSIDE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT INTUBATION DUE TO RENAL FAILURE, AND A DOUBLE LUMEN VENOUS CATHETER WAS PLACED AT 15:30. AT 16:00, BEDSIDE CRRT TREATMENT WAS PERFORMED, AND AT 17:00, CONTINUOUS BLEEDING FROM THE VENOUS END OF THE DOUBLE LUMEN CATHETER WAS FOUND. EXAMINATION REVEALED A MINIMAL CRACK IN THE VENOUS END OF THE CATHETER. DURING CRRT TREATMENT HEMORRHAGE WAS OBVIOUS, AND THE HEMORRHAGE WAS TEMPORARILY REDUCED BY THE DOCTOR AFTER WRAPPING IT WITH A TRANSPARENT DRESSING. AFTER THAT, THE CATHETER WAS REPLACED FOR TREATMENT. IT WAS SUSPECTED THAT THE CENTRAL VENOUS CATHETER HAD QUALITY PROBLEMS. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, AND FLUSHING WAS DONE PRIOR TO USE WITH NORMAL SALINE FLUSHING. THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR, THE CLEANING AGENT UTILIZED TO CLEAN THE ADAPTERS WAS IODOPHOR, THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA, THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED ON THE DEVICE. INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143775 ↗
• MalfunctionJun 30, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PROCEDURE/OPERATION. THE GUIDE WIRE COULD NOT PASS THROUGH THE CATHETER TIP OF THE TEMPORARY TUBE, AND THE CATHETER WAS TAKEN OUT TOGETHER WITH THE GUIDE WIRE. THE GUIDEWIRE THAT WAS PROVIDED WITH THE KIT, THE ONE BEING USED. 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 USED DURING INSERTION/REMOVAL. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL. THERE WAS NO RESISTANCE NOTED AND NO OCCLUSION NOTED. IT WAS STATED THAT ALL PIECES OF THE GUIDEWIRE WERE ACCOUNTED FOR AND HAD NO BROKEN PIECES. THE CATHETER WAS NOT REPAIRED. NO ANY VISIBLE DEFECTS ON THE GUIDEWIRE. NO BLOOD LOSS AND BLOOD TRANSFUSIONS WERE NOT REQUIRED. NO MEDICAL INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. NO CLEANING AGENT USED ON THE DEVICE AND ON THE INSERTION SITE. IODOPHOR DISINFECTION WAS THE CLEANING AGENT USED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE AND COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14878987 ↗
• MalfunctionJun 21, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, DURING CATHETER PLACEMENT, WHILE INSERTING THE GUIDE WIRE (INCLUDED IN THE CATHETER KIT) INTO THE PATIENT, IT WAS FOUND TO BE IN A STRETCHED STATE, AND SO IT WAS NOT CONTINUED TO BE USED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE, GUIDEWIRE HAD NO PROBLEM, AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND IN THE PRODUCT. THE INSERTION SITE WAS TREATED WITH AN ORDINARY DISINFECTION TREATMENT PRIOR TO PRODUCT PLACEMENT, THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE, NO EXCESSIVE FORCE WAS USED ON THE DEVICE, THE CLEANING AGENT USED ON THE DEVICE WAS IODOPHOR, TEGO WAS NOT UTILIZED, AND THE CATHETER WAS NOT REPAIRED. IT WAS STATED THAT THE GUIDEWIRE WAS REMOVED BY HAND AND IT WAS NECESSARY TO REMOVE THE GUIDE WIRE AND CATHETER FROM THE PATIENT SIMULTANEOUSLY (IN ONE ACTION) DUE TO THE ALLEGED DEFECT. THE GUIDEWIRE WAS IN AN UNCOILED STATE WHEN REMOVED AND IT DID NOT BREAK INTO FRAGMENTS (ALL COMPONENTS WERE STILL ON ONE GUIDE WIRE AND NOT DROPPED). ALL PIECES WERE ACCOUNTED FOR, AND X-RAY WAS NOT REQUIRED TO CHECK IF ALL PIECES WERE ACCOUNTED FOR. THE PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14755066 ↗
• MalfunctionJun 15, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT ON THE SECOND DAY OF CATHETER PLACEMENT, IT WAS FOUND THAT THERE WAS LEAKAGE AND A SMALL HOLE THAT COULD ALMOST BE IGNORED IN THE SILICONE EXTENSION TUBE OF THE VENOUS SEGMENT NEAR THE BIFURCATE. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE AND THERE WAS ALSO NOTHING UNUSUAL FOUND, NO OTHER PRODUCTS WAS UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE INSERTION SITE WAS TREATED/DISINFECTED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE AND ALSO THE TYPICAL CLEANING AGENT UTILIZED TO CLEAN THE ADAPTERS. TEGO WAS UTILIZED. THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THE CATHETER WAS NOT REPAIRED, AND INTERVENTION/TREATMENT WAS NOT REQUIRED AS A RESULT OF THE EVENT. A SURGERY WAS RE-PERFORMED FOR TUBE REPLACEMENT AND THE SURGERY WAS COMPETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS IN STABLE STATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14707710 ↗
• MalfunctionJun 15, 2022Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING FLUSHING, IT WAS FOUND THAT THE TIP OF THE CATHETER WAS NOT STRAIGHT (IT WAS BENT). DESPITE THE ISSUE, THEY STILL PROCEEDED WITH CATHETER PLACEMENT AND WHEN THEY TRIED THE GUIDE WIRE, IT COULD NOT BE DELIVERED (IT DID NOT ADVANCE) DUE TO THE ANGLE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND THEY FOUND THAT THE TIP WAS BENT. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IODOPHOR (IODINE V) WAS THE CLEANING AGENT USED ON THE DEVICE AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED WITH IODOPHOR AND SALINE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO CHANGE AFTER REPEATED ATTEMPTS, AND THE SURGERY WAS COMPLETED AFTER CHANGING THE PRODUCT WITH A NEW ONE FROM ANOTHER VENDOR. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS 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 14707364 ↗
• MalfunctionJun 15, 2022Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING FLUSHING, THE TIP OF THE CATHETER WAS FOUND TO BE NOT STRAIGHT (IT WAS BENT). DESPITE THE ISSUE OBSERVED, THEY STILL PROCEEDED WITH CATHETER IMPLANTATION AND WHEN THEY TRIED TO USE AND SEND THE GUIDE WIRE DOWN, THERE WAS AN ANGLE THAT CAUSED THE GUIDE WIRE NOT TO BE DELIVERED OR ADVANCED TO THE SURGICAL SITE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IODOPHOR (IODINE V) WAS THE CLEANING AGENT USED ON THE DEVICE AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED WITH IODOPHOR AND SALINE PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH A NEW PRODUCT FROM A DIFFERENT VENDOR TO COMPLETE THE SURGERY. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS 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 14707342 ↗
• MalfunctionJun 13, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO REPORTER, DURING DIALYSIS TREATMENT, THE CENTRAL VENOUS CATHETER (CVC) WAS NOT GOOD. IT WAS STATED THAT IT DID NOT HAVE AN EXCELLENT PERFORMANCE IN THE FLOW. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680875 ↗
• MalfunctionMay 23, 2022Material Fragmentation; Product Quality Problem; Difficult to Remove; Obstruction of Flow; Material Fragmentation; Product Quality Problem; Difficult to Remove; Obstruction of Flow

  ACCORDING TO THE REPORTER, INITIALLY THERE WAS A PROBLEM INSERTING THE CVC (CENTRAL VENOUS CATHETER) INTO THE RIGHT FEMORAL. IT WAS STATED THAT THE CATHETER IMMEDIATELY HAD PROBLEMS AND WAS REMOVED. THE FOLLOWING DAY, THE CUSTOMER REPORTED THAT THE GUIDE WIRE DID NOT PASS. IT WAS STATED THAT IT WAS PLACED FOR START OF CHRONIC DIALYSIS AND PLACEMENT WAS SAID TO BE ULTRASOUND GUIDED. THE FUNCTIONALITY WAS SUFFICIENT AND WITH HEPARIN LOCK. VENOUS PRIMING WAS 1.3 AND ARTERIAL PRIMING WAS 1.2. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14481366 ↗
• MalfunctionApr 22, 2022Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING TREATMENT, THE VENOUS END OF THE DEVICE WAS FOUND TO BE PROLONGED AND DAMAGED (HOLE). THERE WAS A LEAK AT THE VENOUS EXIT SITE. THE TREATMENT WAS COMPLETED AFTER THE DEVICE WAS REPLACED, THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED FOR THE LEAKAGE, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS PERFORMED WITH NORMAL RESULT. THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, IODOPHOR DISINFECTION WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THE CLAMPS WERE MOVE TO A NEW POSITION AFTER EACH TREATMENT, THERE WAS NO CLEANING AGENT USED TO CLEAN THE ADAPTERS AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE CATHETER WAS NOT REPAIRED, THERE WAS NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188265 ↗