Permcath 8817748001Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521009868), received between Mar 23, 2017 and Sep 19, 2024 — classified as 2 deaths, 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING INTUBATION OF THE CATHETER, THE CATHETER SHAFT WAS KINKED AND THE CATHETER COULD NOT BE PLACED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS NOT DONE PRIOR TO USE. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT ON THE SAME DAY, AND THIS RESOLVED THE ISSUE AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257166 ↗
• MalfunctionJul 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD THREE HOLES IN THE BODY. THERE WAS A LEAK ON THE CATHETER SHAFT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT USED. THERE WAS NO PROBLEM WITH LUER ADAPTER. NO DISINFECTANT WAS USED TO DISINFECT THE CATHETER. NO WOUND DRESSING HAD BEEN USED. SEPSIDERM TO CLEAN THE CATHETER WAS NOT USED. NO PROTOCOL WAS CHANGED FOR CLEANING AGENTS USED RECENTLY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE, AND NO ABNORMALITIES WERE FOUND. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. AS A REMEDIAL ACTION, THE SURGEON REPLACED IT ON THE SPOT WITH A NEW CATHETER FOR THE PATIENT. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EV ENT. NO INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE REPORTED PRODUCT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813152 ↗
• MalfunctionNov 10, 2023Product Quality Problem; Unraveled Material; Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, DURING CATHETERIZATION SURGERY, THE GUIDE WIRE WITHIN THE KIT HAD BEEN USED, WAS STUCK IN THE NEEDLE TIP UPON REMOVAL OR WITHDRAWAL, AND IT WAS WORN. HOWEVER, IT WAS STATED THAT THE GUIDE WIRE AND THE NEEDLE DID NOT NEED TO BE REMOVED FROM THE PATIENT SIMULTANEOUSLY DUE TO THE ALLEGED DEFECT, AS THE GUIDEWIRE WAS REMOVED ALONE. THE GUIDE WIRE WAS REMOVED BY HAND, AND NO TOOLS WERE USED. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS STILL INTACT AND SLIGHTLY BENT WHEN IT WAS REMOVED, BUT IT WAS NOT BENT AND WAS NOT WORN WHEN UNPACKING AND PRIOR TO INSERTION INTO THE PUNCTURE NEEDLE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS DONE PRIOR TO USE WITH A NORMAL RESULT. TEGO WAS NOT UTILIZED, AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. IOD OPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115020 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE PULLING OUT/REMOVING THE GUIDE WIRE, IT WAS STUCK AND DEFORMED (UNTANGLED). THE GUIDE WIRE WAS NEEDED TO BE TAKEN OUT TOGETHER WITH THE NEEDLE/CATHETER IN ONE ACTION. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. FLUSHING WAS DONE PRIOR TO INSERTION AND HAD A NORMAL OUTCOME. THE GUIDE WIRE USED WAS ONE INCLUDED IN THE KIT. EXCESSIVE FORCE WAS APPLIED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE AND THERE WAS NO RESISTANCE WHEN INSERTING THE GUIDE WIRE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION AND THERE WAS NO OCCLUSION NOTED. THE GUIDE WIRE WAS INTACT, DID NOT BREAK INTO PIECES AND IT WAS REMOVED MANUALLY. THE PRODUCT WAS REPLACED WITH A NEW DEVICE FROM A DIFFERENT VENDOR TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS OF ABOUT 1ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946018 ↗
• MalfunctionSep 13, 2023Break; Break

  ACCORDING TO THE REPORTER, APPROXIMATELY TWO MONTHS AFTER THE CATHETERIZATION PROCEDURE WAS PERFORMED, BLOOD LEAKAGE WAS FOUND IN THE MAIN BODY. ALSO, A LEAK WAS FOUND AT THE CATHETER SHAFT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE PATIENT WAS TREATED WITH LOCAL ANESTHESIA. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, AND THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THE LUMENS WERE NOT FLUSHED PRIOR TO USE. THERE WERE NO DEFECTS OR DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. IODOPHOR WAS USED AS A CLEANING AGENT TO CLEAN THE CATHETER, AND GAUZE WAS USED FOR WOUND DRESSING. THERE WERE NO CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES INCLUDED IN THE WOUND DRESSING. THE CLEANING AGENT WAS DRIED THOROUGHLY PRIOR TO DRESSING THE AREA AND APPLYING THE OINTMENT TO IT. THE PATIENT WAS NOT RESPONSIBLE FOR THE CATHETER MAINTENANCE. THE PATIENT WAS NOT USING ANY TYPE OF ANTIBIOTIC ON THE CATHETER. THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE OF THE CATHETER AND WAS NOT MIXED. SEPSIDERM WAS NOT USED TO CLEAN THE CATHETER. THERE WERE NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741191 ↗
• MalfunctionMay 26, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, FOUR DAYS AFTER IMPLANTATION, DURING DIALYSIS TREATMENT, THE PRODUCT HAD ARTERIAL (RED) LUMEN TIP OR VENOUS (BLUE) END BLOCKAGE, AFFECTING THE PATIENT'S DIALYSIS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSIONS. THE DIMENSION OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL. NO CLEANING AGENT WAS USED ON THE DEVICE. NO TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE CUSTOMER TRIED TO REVERSE THE LINES. THEY ADJUSTED THE CATHETER'S POSITION AND SEALED THE TUBE WITH UROKINASE. CONTINUOUS UROKINASE SEALING WAS THE INTERVENTION OR TREATMENT USED. AFTER CONTINUOUS UROKINASE LOCK FOR SEVERAL DAYS, CATHETER PATENCY WAS OBSERVED. THEY STILL REMOVED AND REPLACED THE TEMPORARILY LONG-TERM TUBE WITH A NEW ONE WITH THE SAME PRODUCT ID (IDENTIFIER) ON (B)(6) 2023. THE TREATMENT WAS PERFORMED AND COMPLETED AFTERWARDS. THE PROCUREMENT CENTER HAD CONTACTED THE SUPPLIER TO COME TO THE HOSPITAL TO CHECK AND REPLACE THE PROBLEMATIC BATCH. THERE WAS NO BLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010626 ↗
• InjuryMay 15, 2023Break; Migration; Break; Migration

  ACCORDING TO THE REPORTER, THE CATHETER WAS DECIDED TO BE WITHDRAWN/REMOVED BECAUSE THERE WAS ALREADY A FUNCTIONAL FISTULA, AND THE CATHETER WAS NO LONGER NEEDED. HOWEVER, DURING REMOVAL IN OPERATING ROOM (OR), THE CATHETER WAS RUPTURED. IT WAS STATED THAT THE LUMP (BROKEN CATHETER PIECE) OF APPROXIMATELY 10 CM (CENTIMETER) HAD FELL INTO THE PATIENT¿S BODY AND MIGRATED INTO THE LEFT PULMONARY ARTERY WITH HYPOXIC RESPIRATORY DISTRESS AND CHEST PAIN. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO PRESCRIBED/OVER-THE-COUNTER TREATMENT (LOTIONS/OINTMENTS). THE SITE WAS NOT USING SEPSIDERM TO CLEAN CATHETERS. THERE WAS NO RECENT CHANGE IN PROTOCOL FOR CLEANING AGENTS USED. THE BLOCK (MIGRATED PIECE) WAS ATTEMPTED TO BE REMOVED IN THE FACILITY¿S OPERATING ROOM (OR) ON THE SAME DAY OF THE EVENT, BUT THE PATIENT WAS DISCHARGED FROM INTENSIVE CARE UNIT TO NEPHROLOGY WITH NO RETURN TO BASIC STATE IN WHICH HE WAS AT THE ADVENT OF THE INCIDENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT SURGICAL CENTER ON APRIL 25, 2023 FOR 48 HOURS FOR ENDOVASCULAR ABLATION TO REMOVE THE MIGRATE

  Patient problems: Chest Pain; Foreign Body In Patient; Respiratory Insufficiency

  MAUDE report 16929885 ↗
• MalfunctionApr 21, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS FLUSHED BEFORE THE SURGERY, IT WAS FOUND THAT THE VENOUS SILICONE EXTENSION TUBE HAD LEAKED WATER NEAR THE BIFURCATE WHERE HOLES/CUT OBSERVED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. NO DAMAGE TO THE OUTER PACKAGING. NO DAMAGE TO THE INNER PACKAGING AND THE STERILE BARRIER WAS INTACT. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. NO CLEANING AGENT USED ON THE DEVICE. THE PRODUCT WAS NEVER IMPLANTED, IT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND SAME LOT ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788375 ↗
• MalfunctionMar 29, 2023Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS FLUSHED PRIOR TO USE, THERE WAS A CRACK AND LEAK AT THE JUNCTION OF THE MAIN CATHETER BODY OR SHAFT AND BIFURCATE. NO DAMAGE TO THE OUTER PACKAGING AND TO THE INNER PACKAGING. THE STERILE BARRIER WAS INTACT. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE PRODUCT WAS NEVER IMPLANTED AND IT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND SAME LOT ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637969 ↗
• MalfunctionSep 7, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING PRIMING, A HOLE NEAR THE CATHETER SHAFT KRAFT (CUFF- WHITE POLYESTER SLEEVE STRUCTURE ON THE CATHETER, WHICH IS USED ON THE CATHETER BODY TO ADHERE TO THE SUBCUTANEOUS TISSUE TO PREVENT THE CATHETER FROM SLIPPING) WAS FOUND AND LEAKED FLUID. THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZEDAND NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE, WAS SUCCESSFULLY USED AND COMPLETED THE PROCEDURE. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374296 ↗
• InjuryAug 23, 2022Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, AFTER ONE WEEK OF USE, THE CATHETER HAD A CRACK. THERE WAS A LEAK. IT WAS ALSO STATED THAT FEVER AND DETERIORATION OF THE CHILD'S CONDITION WAS THE PATIENT'S CURRENT STATUS. POSSIBLE INFECTION RELATED TO THE LEAK. THE ACTIONS TAKEN IN THE FACILITY WERE TO MANAGE THE PATIENT AND REMOVED THE CATHETER. THE CATHETER WAS SET ASIDE AND SENT TO THE LABORATORY FOR EXPERTISE.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 15276364 ↗
• MalfunctionMar 23, 2022Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT NEEDED TO INDWELL A HEMODIALYSIS CATHETER DUE TO RENAL FAILURE. AFTER CATHETERIZATION, IT WAS FOUND THAT THERE WAS A FISSURE AND LEAKAGE IN THE SILICONE TUBE AT THE LOWER END OF THE CATHETER (NEAR THE CUFF). THE CATHETER WAS NOT REPAIRED AND IODOPHOR WAS THE CLEANING AGENT USED THE HE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. PRIOR TO USE, THERE WAS NO ABNORMALITY OBSERVED ON THE DEVICE AND THE CATHETER WAS PRE-FLUSHED AND HAD A MOIST IN ITS RESULT. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. STERILE GAUZE WAS THE WOUND DRESSING USED WHICH ALSO DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIBACTERIAL PROPERTIES. THE CLEANING AGENT WAS NOT ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA AND THE CLEANING AGENTS WERE NEVER MIXED. THE CATHETER HAS NOT BEEN CLEANED WITH SEPSIDERM AND THE PATIENT DID NOT USE ANY TYPE OF CLEANER OR ANTIBIOTIC ON THE CATHETER. THEY CHANGED TO A NEW HEMODIALYSIS CATHETER FROM ANOTHER MANUFACTURER TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS 5 ML OF BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO TR

  Patient problems: Insufficient Information

  MAUDE report 13866329 ↗
• MalfunctionDec 20, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, BEFORE INTUBATION, WHEN THE CATHETER WAS CHECKED, IT WAS FOUND THAT THE CONNECTION BETWEEN THE VENOUS SILICON GEL AND THE EXTERNAL JOINT WAS BROKEN AND HAD A CRACK. THERE WAS NO INTERVENTION/TREATMENT AS A RESULT OF THE LEAKAGE BECAUSE IT WAS NOT IMPLANTED, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS NOT PERFORMED, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WAS NO DAMAGE TO THE DEVICE'S EXTERNAL PACKAGING AND BOX. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK VENOUS SILICON GEL AND THE EXTERNAL JOINT OF THE CATHETER. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043352 ↗
• MalfunctionSep 13, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING SURGERY AFTER THE SURGICAL INTUBATION WAS COMPLETED, THEY FOUND THAT THE SOUND WAS WRONG, AND THEN NOTICED THAT THE CATHETER RUPTURED, THE BODY(SHAFT) OF THE CATHETER WAS BROKEN BELOW THE CUFF. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED AND THEY FOUND THAT THE CATHETER WALL WAS CRACKED. PATIENT WAS ON LOCAL ANESTHESIA. THERE WAS NOTHING UNUSUAL OBSERVED PRIOR TO USE. THERE WAS ALSO NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND NO EXCESSIVE FORCE WAS USED ON THE CATHETER. INSERTION SITE WAS TREATED WITH NORMAL CLEANING AND DISINFECTION. THE CATHETER WAS NOT REPAIRED AND THERE WAS A LEAK IN THE CATHETER'S BODY(SHAFT). TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS, NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT AND X-RAY OR ANY FORM OF IMAGING WAS NOT REQUIRED. IT WAS ALSO STATED THAT ALL PARTS OF THE CATHETER HAVE BEEN TAKEN OUT AND THERE WAS NO PART OF THE CATHETER LEFT IN THE PATIENT¿S BODY. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462275 ↗
• MalfunctionAug 24, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR EXAMINED THE CATHETER BEFORE THE OPERATION, THERE WAS A SLIGHT BREAKAGE FOUND NEXT TO THE CATHETER'S KRAFT. AS THERE HAD BEEN BLOOD LEAK IN THE SAME TYPE OF CATHETER IN THE SAME POSITION ON DIFFERENT OCCASIONS/EVENTS, THE DOCTOR GAVE UP USE. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE DEVICE'S BOX AND PACKAGING, AND THE STERILE BARRIER WAS INTACT. THE PRODUCT WAS NOT EXPIRED AND THERE WAS NO EXCESSIVE FORCE USED TO PULL/TAKE OUT THE PRODUCT. THE PRODUCT WAS REPLACED WITH A CATHETER ON THE SAME DAY OF THE EVENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362228 ↗
• MalfunctionAug 5, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN PREPARING THE CATHETER FOR IMPLANTATION, IT WAS FOUND THAT THERE WAS A SMALL HOLE ON THE CATHETER'S BODY. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK, THERE WAS NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282089 ↗
• MalfunctionAug 4, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN THE TUBE WAS CHECKED BEFORE INTUBATION, A HOLE AND A LEAK WAS FOUND AT THE END OF THE INTRAVENOUS SILICONE TUBE (BLUE). NO DAMAGE NOTED ON THE DEVICE PACKAGING. THE STERILE BARRIER AND THE BOX THAT THE DEVICE CAME IN WERE INTACT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT WAS USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THEY REPLACED THE PRODUCT TO RESOLVE THE ISSUE (THEY PULLED OUT ANOTHER ONE). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274307 ↗
• MalfunctionFeb 3, 2021Break; Break

  HOLD FOR CR 10/17

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 11271620 ↗
• MalfunctionDec 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING USE FOR DIALYSIS, BLOOD LEAK WAS NOTED ON THE BIFURCATE/EXTENSION TUBE JUST AFTER THE HUB. THE CATHETER WAS NOT REPAIRED, IODOPHOR WAS THE CLEANING AGENT USED PRIOR TO PRODUCT PLACEMENT, TEGO WAS NOT UTILIZED, THERE IS NO LUER ADAPTER ISSUE. THE CATHETER WAS REPLACED AS INTERVENTION FOR THE LEAKING. THE PROCEDURE WAS NOT COMPLETED, THERE WAS BLOOD LOSS OF LESS THAN 1ML AND NO TRANSFUSION WAS REQUIRED. NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE AND PRE FLUSHING WAS DONE. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003367 ↗
• MalfunctionDec 9, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE DEVICES VENOUS END (BLUE) CONNECTOR WAS BROKEN (CRACK WAS OBSERVED). IT WAS STATED THAT THE CATHETER WAS REPAIRED AND THE EXTERNAL SHORT TUBE WAS REPLACED. FLUSHING WAS DONE AND IT WAS WHEN ISSUE WAS OBSERVED DUE TO OOZING BLOOD. NO OTHER DEFECTS/DAMAGES WAS NOTED THAN WHAT WAS OBSERVED. IODOPHOR WAS THE CLEANING AGENT USED TO CLEAN THE ADAPTERSSAME WITH THE INSERTION SITE (DISINFECTION) AND WAS ALLOWED TO THOROUGHLY DRY PRIOR TO APPLYING OINTMENTS ON THE AREA. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENT WAS USED AND TEGO WAS NOT UTILIZED. NO TOOLS WAS USED TO TIGHTEN OR LOOSEN THE ADAPTER. THERE WAS NO BLOOD LOSS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977832 ↗
• MalfunctionJun 30, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED ON THE PATIENT AND WHEN THE HEMODIALYSIS WAS PERFORMED, IT FAILED. IT WAS MENTIONED THAT IT WAS BROKEN AND THERE WAS A LEAK ON THE CATHETER SHAFT. IT WAS NOT LEAKING AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THEY NEEDED TO CHANGE THE CATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND IT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213541 ↗
• MalfunctionJun 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER THE CATHETER WAS IMPLANTED, THE PATIENT WAS SAID TO HAVE A REGULAR DIALYSIS TREATMENT FOR THREE TIMES A WEEK. HOWEVER ALMOST A MONTH LATER, THE PATIENT HAD ACCIDENTALLY FELL AND CAUSED THE CATHETER TO COME OUT. IT WAS FOUND OUT LATER IN THE HOSPITAL THAT THE DEVICE WAS BROKEN AT THE "KRAFT" (CUFFS WHICH ARE THE FELT TISSUE ON THE TUNNEL TYPE CATHETER, ALSO KNOWN AS THE POLYESTER SLEEVE, WHICH IS THE MOST IMPORTANT POINT TO DISTINGUISH THE NON-TUNNEL TYPE CATHETER) NEAR THE EXTENSION TUBE AND GOT DISCONNECTED AT ONE END. IT WAS MENTIONED THAT THE TUBE WAS NOT DISCONNECTED DURING DIALYSIS SO THERE WAS NO MACHINE ALARM NOR MACHINE PARAMETERS INVOLVED. THE PATIENT HAD TO BE CHECKED AND TRANSFERRED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO CLEANING AGENT WAS USED ON THE DEVICE, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND IT WAS SAID THAT THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS STATED THAT PRIOR TO THE INCIDENT, THE PATIENT HAD NO ISSUES WITH THE DEVICE AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT. THE DEVICE WAS REPORTED TO HAVE BEEN REMOVED BUT WAS DISCARDED AND LOST. REPLACEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174857 ↗
• MalfunctionApr 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING USE FOR DIALYSIS, IT WAS NOTED THAT BLOOD WAS OOZING FROM THE CATHETER SHAFT. IT WAS STATED THAT CATHETER WAS INSERTED 7 WEEKS PRIOR AND WAS USED NORMALLY. THERE WAS AN UNSPECIFIED BLOOD LOSS BUT NO TRANSFUSION WAS DONE. THE CATHETER WAS NOT REPAIRED, IODOPHOR WAS THE CLEANING AGENT USED, POVIDONE IODINE WAS USED TO CLEAN THE CATHETERS ENTIRETY, GAUZE WRAP WAS THE WOUND DRESSING USED AND HAVE NO ANTIMICROBIAL PROPERTIES, CLEANING AGENTS ARE ALLOWED TO DRY PRIOR TO DRESSING THE AREA, NO OINTMENT WAS USED, PATIENTS ARE NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE (CLEANING AGENT OR ANTIBIOTIC), TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE, CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929677 ↗
• MalfunctionOct 1, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING TREATMENT, A CRACK WAS FOUND IN THE ARTERIAL LUER ADAPTER, A LEAKAGE WAS OBSERVED AS WELL. THE TREATMENT WAS COMPLETED AFTER REPLACING THE CATHETER. NOTHING UNUSUAL OBSERVED PRIOR TO USE, CATHETER LUMENS FLUSHED PRIOR TO USE WITH SALINE, INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT WITH BETADINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143533 ↗
• MalfunctionFeb 3, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, LEAKAGE FROM THE EXIT SITE WAS OBSERVED AT THE JUNCTION OF THE HUB AND THE CATHETER SHAFT. THE CATHETER WAS EXPLANTED AND REPLACED WITH A SIMILAR CATHETER, NO LEAKAGE OBSERVED IN THE REPLACEMENT CATHETER. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LUER ADAPTER ISSUE, AND TEGO WAS NOT UTILIZED, NO OTHER DEVICES WERE UTILIZED BY THE DEVICE, THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WAS BLOOD LOSS OF 5ML AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8300595 ↗