MAHURKAR 8888145251Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521014220), received between Jun 22, 2017 and Dec 27, 2024 — classified as 1 death, 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (18 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111372); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1320-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER HAD ARTERIAL LINE BLOCKAGE, AND THE FLOW DID NOT HAPPEN. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. SALINE WATER WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS REPLACED WITH THE SAME LOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027709 ↗
• MalfunctionMay 10, 2024Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING THE TREATMENT, THERE WAS SOME BLOCKAGE IN THE CATHETER AND DID NOT GET THE FLOW FROM THE CATHETER. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NORMAL SALINE WAS USED TO FLUSH THE CATHETER AS CLEANING AGENT. TEGO WAS NOT UTILIZED. FLUSHING PERFORMED PRIOR TO USE WITH NORMAL SALINE AND IT WAS FOUND OKAY. HEPARIN WAS USED. THEY TRIED REVERSE FLOW BUT FOUND LINE BLOCKED AND DID NOT GET THE FLOW. THEY HAD PROVIDED ANOTHER CATHETER ON THE NEXT DAY WITH THE SAME PRODUCT ID (IDENTIFIER). THE TREATMENT COMPLETED AFTER THE RESOLUTION WAS DONE. NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIR ED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19292392 ↗
• MalfunctionApr 24, 2024Obstruction of Flow; Scratched Material; Obstruction of Flow; Scratched Material

  ACCORDING TO THE REPORTER, BEFORE TREATMENT, WHEN CHECKING THE FLOW USING NORMAL SALINE FROM THE PORT, AND IT WAS NOT CLEARLY PASS ON FROM THE CATHETER AND IT WAS FOUND THAT THE RED PORT WAS BLOCKED. THERE WAS NO DIMENSION ISSUE IN THE CATHETER. VISIBLE EXTERNAL DAMAGE WAS NOTED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE CLEANING AGENT USED ON ALL DEVICES WAS NORMAL SALINE FOR FLUSHING THE CATHETER. TEGO WAS NOT UTILIZED. THE CATHETER WAS NOT REPAIRED .NO OTHER PRODUCTS BEING UTILIZED WITH THE REPORTED DEVICES. EXCESSIVE FORCE WAS NOT USED ON THE REPORTED DEVICE. THE INSERTION SITE WAS NOT TREATED WITH PRIOR TO PRODUCT PLACEMENT. THE PACKAGING WAS NOT DAMAGED. THE PRODUCT WAS REPLACED WITH ANOTHER CATHETER AS A REMEDIAL ACTION. THE TREATMENT WAS COMPLETED AFTER RESOLVING THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176879 ↗
• MalfunctionJan 27, 2023Break; Break

  ACCORDING TO THE REPORTER, THE ARTERIAL (RED) PORT HUB WAS EASILY BROKEN (CRACK) AND LEAK WAS OBSERVED ON A NEWLY INSERTED CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16254330 ↗
• MalfunctionJan 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A ROUTINE HEMODIALYSIS SESSION, THE ARTERIAL (RED) PORT HUB WAS EASILY BROKEN (CRACK) AND LEAK WAS OBSERVED ON A NEWLY INSERTED CATHETER. THE CATHETER WAS NOT REPAIRED. CHLORHEXIDINE WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE STANDARD PRACTICE IN THE HOSPITAL REQUIRED COMPLETELY DRYING OF THE CLEANING AGENT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE AS REMEDIAL ACTION. IT WAS SUCCESSFULLY USED AND COMPLETED THE TREATMENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16254249 ↗
• MalfunctionDec 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS SESSION, A CRACKED AT THE BLUE (VENOUS) LUER ADAPTER WAS OBSERVED. THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS NORMAL (NO ISSUE), THERE WERE NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND IT WAS STATED THAT IT WAS NOT HOSPITAL THING TO USE EXCESSIVE FORCE ON THE DEVICE. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE, THE ADAPTERS WERE TIGHTENED BY HAND. THE CLEANING AGENT USED ON THE DEVICE AND TYPICALLY USED WAS OCTANISEPT. THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS WAS OCTENISEPT. THE CLEANING AGENT(S) WERE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. TEGO WAS UTILIZED. AS A RESULT OF THE EVENT THE CATHETER WAS REPAIRED (THE CATHETER¿S ENDING WAS REPAIRED BY HAND WITH NO REPAIR KIT FROM THE SAME BRAND). ASIDE FROM REPAIRING THE CATHETER THERE WAS OTHER REMEDIAL ACTION DONE (SOME REPARATION). THE TREATMENT WAS COMPLETED. THE REPORTED CATHETER REMAINED IMPLANTED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICA TIONS ASSOCIAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073496 ↗
• MalfunctionDec 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A ROUTINE HEMODIALYSIS SESSION, THE ARTERIAL (RED) PORT HUB WAS EASILY BROKEN (CRACK) AND LEAK WAS OBSERVED ON A NEWLY INSERTED CATHETER. THE CATHETER WAS NOT REPAIRED. CHLORHEXIDINE WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE STANDARD PRACTICE IN THE HOSPITAL REQUIRED COMPLETELY DRYING OF THE CLEANING AGENT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE AS REMEDIAL ACTION. IT WAS SUCCESSFULLY USED AND COMPLETED THE TREATMENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. 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 16067014 ↗
• MalfunctionDec 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE NORMAL DIALYSIS PROCEDURE, A CRACK ON BLUE (VENOUS) LUER ADAPTER WAS OBSERVED. THERE WAS ONLY BUBBLE LEAK SEEN ON THE LUER ADAPTER. NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE AND THERE WAS A PROCEDURE IN THE HOSPITAL OF NOT USING ANY INSTRUMENTS BUT ONLY BY HANDS. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND IT WAS ALSO THE CLEANING AGENT TYPICALLY USED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. TEGO WAS UTILIZED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, THE RESULTS WERE NORMAL AND NO ISSUE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE DOCTORS HAD TO USE THE COMPANY'S REPAIR SYSTEM AND THE END OF THE CATHETER WAS REPAIRED AS INTERVENTION ON THE SAME DAY. THE DEVICE WAS USED SUCCESSFULLY AND THE TREATMENT WAS COMPLETED. THE DAMAGE D/REPAIRED LUER ADAPTER PART WOULD NOT BE RETURNED FOR ANALYSIS WHILE THE MAJORITY PART OF THE CATHETER STILL REMAINS IN PATIENT. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT HAD NO AIR EMBOLISM DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16065321 ↗
• MalfunctionDec 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE NORMAL HEMODIALYSIS PROCESS, THERE WAS A CRACK AND LEAK OBSERVED IN THE BLUE (VENOUS) LUER LOCK. HANDS WERE USED TO LOOSEN OR TIGHTEN THE LUER ADAPTER AND NO INSTRUMENT USED. TEGO WAS UTILIZED. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER ENDING WAS REPAIRED AS INTERVENTION AND REMEDIAL ACTION. THE DEVICE WAS SUCCESSFULLY USED AND COMPLETED THE TREATMENT AFTER BEING REPAIRED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WERE NOT REQUIRED. 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 16064390 ↗
• MalfunctionDec 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE HEMODIALYSIS SESSION, A CRACK WAS OBSERVED ON THE BLUE (VENOUS) LUER ADAPTER. THERE WAS SMALL BUBBLES LEAK ON THE LUER ADAPTER. TEGO WAS UTILIZED. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND OCTANISEPT WAS ALSO THE CLEANING AGENT TYPICALLY USED TO CLEAN THE ADAPTER. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE ADAPTERS WERE TIGHTENED BY HAND. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE, THE RESULT WAS NORMAL AND NO PROBLEM. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THE CATHETER WAS REPAIRED AS INTERVENTION ON THE SAME DAY BY HOMEMADE REPAIR, AND THERE WAS NO COMPANY REPAIR KIT. AFTER REPAIRED, THE DEVICE WAS USED SUCCESSFULLY AND TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT HAD NO AIR EMBOLISM DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16063795 ↗
• MalfunctionDec 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE CATHETER'S BLUE LUER LOCK HAD A CRACK. THERE WAS NO DAMAGE NOTED ON THE DEVICE'S PACKAGING AND THE BOX THAT THE DEVICE CAME WAS NOT INTACT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND FLUSHING WAS PERFORMED PRIOR TO USE WITH NORMAL RESULT. THERE WAS NO BLOOD LEAK (JUST BUBBLES), OCTANISEPT WAS USED AS THE CLEANING AGENT ON THE DEVICE, TEGO WAS UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA. THE TREATMENT WAS COMPLETED AND THERE WAS NO REMEDIAL ACTION DONE TO RESOLVE THE ISSUE. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS REPAIRED BY HANDMADE AS THE MEDICAL INTERVENTION DONE DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018259 ↗
• MalfunctionDec 8, 2022Migration; Migration

  ACCORDING TO THE REPORTER, DURING NORMAL USE, UPON VISUAL INSPECTION IT WAS IDENTIFIED THAT THE CATHETER CUFF WAS DISPLACED FROM THE INSERTION/PLACEMENT SITE. THE CATHETER HAS BEEN IN PLACE FOR 20 DAYS. THERE WAS NO LEAK, NO LUER ADAPTER ISSUE AND THERE WAS NO OTHER VISIBLE DEFECT NOTED. THE CUFF DID NOT DETACH FROM THE CATHETER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS DONE WITH NORMAL RESULT, NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT, NO OTHER PRODUCT WAS UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS POVIDONE IODINE, TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION THE REPORTEDCATHETER WAS REMOVED/EXPLANTED. THE REPORTED CATHETER WILL BE REPLACED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947308 ↗
• MalfunctionNov 29, 2022Migration; Migration

  ACCORDING TO THE REPORTER, POST INSERTION, THE CATHETER CUFF DISPLACED. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. PROVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883011 ↗
• MalfunctionNov 14, 2022Migration; Migration

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE CATHETER CUFF DISPLACED WHEREIN IT MOVED FROM ITS PLACE BUT DID NOT DETACH FROM CA THETER. THE PATIENT WAS NOT AT THE HOSPITAL WHEN THE EVENT OCCURRED (NOT ON DIALYSIS SESSION). NO DEFECTS/DAMAGES WERE FOUND ON THE CUFF. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. PROVODINE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. THE CATHETER WAS EXPLANTED AND THE PATIENT DID NOT HAVE A CATHETER REPLACEMENT TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15791301 ↗
• MalfunctionJun 9, 2022Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ACCORDING TO THE REPORTER, AFTER PLACEMENT, THE CATHETER CUFF AND THE CATHETER WAS DISLOCATED, SO THE HEALTH CARE PROVIDER (HCP) HAD TO EXPLANT THE CATHETER ON THE SAME DAY OF THE EVENT. 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 WITH NORMAL RESULT, NO OTHER DEFECTS/DAMAGES WAS FOUND ON THE PRODUCT, NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. THE CLEANING AGENT USED ON THE DEVICE WAS BETADINE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. INTERVENTION/TREATMENT WAS NOT REQUIRED AS A RESULT OF THE EVENT. THE REPORTED CATHETER WAS REPLACED ON(B)(6) 2022. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. 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 14649163 ↗
• MalfunctionMay 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE HD (HEMODIALYSIS) PROCEDURE, IT WAS STATED THAT THE BLUE LUER ADAPTER WAS OBSERVED TO BE DAMAGED HAD A CRACK AND LEAK. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO HEMODIALYSIS. THE CATHETER WAS NOT REPAIRED. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND ALSO THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO INSTRUMENT/DEVICE WAS USED TO LOOSEN OR TIGHTEN THE DEVICE (IT WAS IN THE HOSPITAL PROCEDURE) BUT HANDS WERE USED INSTEAD. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE CATHETER WAS EXPLANTED AND WAS REPLACED (DIFFERENT MANUFACTURER) WHICH RESOLVED THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466384 ↗
• MalfunctionMay 20, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING HEMODIALYSIS TREATMENT, A CRACK AND LEAK WERE OBSERVED ON THE BLUE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED, THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE, THERE WAS A LUER ADAPTER ISSUE, OCTANISEPT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO THE ADAPTERS. IT WAS NECESSARY TO EXPLANT THE CATHETER. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER WAS EXPLANTED AS THE INTERVENTION/TREATMENT AS THE RESULT OF THE ADAPTER ISSUE, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED WITH NORMAL RESULT, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463391 ↗
• MalfunctionJan 28, 2022Break; Break

  ACCORDING TO THE REPORTER, AFTER 48 DAYS OF CATHETER INSERTION, DURING NORMAL WORK OR HD (HEMODIALYSIS) PROCEDURE, THERE WAS A LEAK AT THE BLUE (VENOUS) LUER ADAPTER WHERE A CRACK/BREAK OBSERVED. THE CATHETER WAS NOT REMOVED FROM THE PATIENT. IMMEDIATELY, THE ADAPTER WAS REPAIRED BY HANDMADE SYSTEM WHEREIN THEY USED SOME TUBE FROM OTHER MANUFACTURER¿S PRODUCTS AVAILABLE IN THE HOSPITAL ON THE SAME DAY OF THE EVENT, THE DEVICE WAS USED SUCCESSFULLY AND THE TREATMENT WAS COMPLETED. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND IT WAS THE ONE TYPICALLY UTILIZED ON THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE, THEY TIGHTEN THE ADAPTERS BY HANDS ONLY WHICH WAS A SPECIAL PROCEDURE AND NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. PRIOR TO DIALYSIS, NOTHING UNUSUAL OBSERVED AND FLUSHING WAS DONE WITH NORMAL RESULT. NO EXCESSIVE FORCE USED TO INSERT IN/TAKE OUT BLOODLINE FROM THE LUER ADAPTER. THERE WAS ONE DROP OF BLOOD LOSSAND AIR BUBBLE. THE PATIENT DID NOT HAVE AIR EMBOLISM. BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385927 ↗
• MalfunctionJan 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, IT WAS OBSERVED THAT THE BLUE (VENOUS) LUER ADAPTER HAD A CRACK AND LEAK WAS NOTED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE LUER ADAPTER WAS REPAIRED AS THE INTERVENTION/TREATMENT REQUIRED FOR THE LEAKAGE, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, PRIMING WAS PERFORMED WITH NORMAL RESULT, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THE BLOOD OF THE PATIENT WAS SAFELY RETURNED, THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA. THE TREATMENT WAS COMPLETED AFTER THE LUER ADAPTER WAS REPAIRED BY USING THE HOME MADE METHOD (REPAIRED THE LUER LOCK ADAPTER USING SOME TUBES AND LUER LOCK AVAILABLE IN THE HOSPITAL), THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE, OCTANISEPT WAS USED AS THE CLEANING AGENT ON THE DEVICE AND TO CLEAN THE ADAPTERS. THERE WAS A LUER ADAPTER ISSUE (BROKEN) AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385896 ↗
• MalfunctionDec 30, 2021Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  ACCORDING TO THE REPORTER, DURING THE REMOVAL OF THE DRESSING WHILE SECURING THE CATHETER BEFORE CONNECTING TO THE DIALYSIS, AN EPISODE OF DAMAGE TO THE BLUE (VENOUS) LUER LOCK ADAPTER (TIP) WAS NOTICED. IT WAS SAID THAT THERE WAS A LEAK AND A CRACK NOTED ON THE BLUE (VENOUS) LUER ADAPTER. OCTANISEPT WAS THE CLEANING AGENT USED ON THE DEVICE AND TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE BUT HANDS WERE USED INSTEAD (THERE WAS A SPECIAL PROCEDURE IN THE HOSPITAL - NO INSTRUMENT TO BE USED). NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. 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 IN ORDER TO RESOLVE THE ISSUE, SINCE IT WAS NOT POSSIBLE TO PHYSICALLY CHANGE AND REPAIR ONLY THE VENOUS LUER ADAPTER, ALL THE CATHETER'S EXTENSION (TUBE AND LUER ADAPTER) WERE CHANGED/REPAIRED BY THE DOCTOR OUT OF SERVICE WITH OTHER MANUFACTURER'S PRODUCT (USING SOME PRODUCTS AVAILABLE IN THE HOSPITAL - PRODUCT NAME AND NUMBER NOT AVAILABLE). THE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117895 ↗
• MalfunctionDec 30, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  ACCORDING TO THE REPORTER, DURING DIALYSIS CONNECTION, AN EVENT OF DAMAGED (CRACK) AND LEAK IN THE BLUE (VENOUS) LUER LOCK CONNECTOR TIP WAS NOTICED DURING THE REMOVAL OF THE DRESSING SECURING THE CATHETER. FLUSHING WAS DONE PRIOR TO USE AND IT WAS NORMAL. TEGO WAS UTILIZED. HANDS WERE UTILIZED TO TIGHTEN THE ADAPTERS. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. OCTANISEPT WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS AND ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE EXTENSION AND LUER ADAPTER WERE REPAIRED AS AN INTERVENTION TO RESOLVE THE ISSUE. IT WAS USED SUCCESSFULLY AND COMPLETED THE TREATMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117872 ↗
• MalfunctionDec 30, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING THE REMOVAL OF THE DRESSING WHICH SECURE THE CATHETER BEFORE CONNECTING TO THE DIALYSIS, THE DEVICE'S VENOUS LUER LOCK ADAPTER WAS DAMAGED. THE CATHETER'S EXTENSION TUBE WAS REPAIRED WITH ANOTHER MANUFACTURER'S PRODUCT AS THE INTERVENTION/TREATMENT REQUIRED FOR THE LEAKAGE. THE TREATMENT WAS PROCEEDED AND COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT, OCTANISEPT WAS USED AS THE CLEANING AGENT TO CLEAN THE ADAPTER AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA. THERE WAS A LEAK AND CRACK AT THE VENOUS (BLUE) LUER ADAPTER. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE AND TEGO WAS UTILIZED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117868 ↗
• InjuryAug 17, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN REPLACING THE OLD CATHETER (COMPETITOR'S CATHETER) WITH A NEW ONE DUE TO DAMAGE, IT WAS SAID THAT WHILE INSERTING THE CATHETER INTO THE VEIN, LEAKAGE WAS NOTED AT THE CHECK VALVE PULL APART SHEATH. NOTHING UNUSUAL OBSERVED PRIOR TO THE PROCEDURE. THERE WAS NO PACKAGE DAMAGE. THE CATHETER WAS NOT REPAIRED. TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED (CRACK, CUT, ETC.). NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. LEAKAGE WAS MODERATE AND REQUIRED A MEDIUM AMOUNT OF GAUZE PADS. THERE WAS A SMALL AMOUNT OF BLOOD LOSS BUT NO BLOOD TRANSFUSION WAS REQUIRED. FLUID THERAPY WAS ABOUT 500 ML. BLOOD BLOCKING AND VERY QUICK CATHETER INSERTION TO THE VEIN WERE DONE TO RESOLVE THE LEAKAGE ON THE SHEATH AND NO OTHER MEDICAL INTERVENTION/TREATMENT WAS PROVIDED DUE TO THE EVENT. THEY DID NOT PULL OUT ANOTHER CATHETER KIT AS THE CATHETER WAS USED DESPITE OF THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY AND THE FINAL PATIENT OUTCOME WAS GOOD.

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

  MAUDE report 12331240 ↗
• InjuryAug 17, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, WHEN REPLACING THE CATHETER WITH A NEW ONE, WHILE INSERTING THE CATHETER INTO THE VEIN, THE CHECK VALVE IN THE PULL APART SHEATH WAS LEAKING. CONSIDERABLE OUTFLOW, LARGE FLOODING OF THE TREATMENT AREA OCCURRED. SERVIETTING AND BLOCKING THE OUTFLOW WITH GAUZE WAS REQUIRED. FLUIDOTHERAPY WITH CRYSTALLOID SOLUTIONS WAS PERFORMED. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 12331185 ↗
• MalfunctionJul 29, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING CONNECTION PROCESS, AT THE TIME OF WASHING/FLUSHING THE VENOUS LUMEN, A "PROJECTILE"-TYPE BLOOD LEAK WAS OBSERVED IN A SMALL AMOUNT, A FRACTURE IN THE VENOUS LUMEN WAS NOTED. THE PHYSICIAN WAS INFORMED WHO GENERATED AN ORDER TO CHANGE THE CATHETER AND CATHETER WAS REPLACED THE SAME DAY THE EVENT WAS REPORTED. THE PATIENT COULD NOT BE CONNECTED AND THE TREATMENT WAS SUSPENDED. CHLORHEXIDINE GLUCONATE 2% WAS THE CLEANING AGENT USED. THERE WAS BLOOD LOSS OF LESS THAN 150ML AND NO TRANSFUSION WAS REQUIRED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. TREATMENT WAS SCHEDULED THE NEXT DAY AND WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339713 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1316-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.