Argyle 8888415604Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521004740), received between Jun 4, 2021 and Sep 10, 2024 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (36 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, UPON TAKING THE ADAPTER OUT OF THE PACKING, THE TITANIUM CAP DID NOT PROVIDE A PROPER SEAL WHEN SCREWED ONTO THE ADAPTER. IT APPEARED THAT THE SCREW MECHANISM (THE THREAD) WAS DEFECTIVE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE DEFECTIVE ADAPTER WAS REPLACED BY ANOTHER ADAPTER WHICH TOOK MORE TIME FROM DIFFERENT LOT NUMBER AND SAME PRODUCT ID (IDENTIFIER) ON THE SAME DAY, WHICH WAS FUNCTIONED PROPERLY AND THIS RESOLVED THE ISSUE. THERE WAS NO BLOOD LOSS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181432 ↗
• MalfunctionApr 11, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, IN THE OPERATING ROOM, THEY STILL HAD PROBLEM WITH THE TITANIUM CAPS FOR THE KIT. INDEED, THE CAPS, WHEN THEY SCREWED THEM COMPLETELY, WERE UNSCREWABLE AFTERWARDS (AND MUST BE) AND SOME CANNOT BE COMPLETELY SCREWED IN. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 19093494 ↗
• MalfunctionDec 13, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, WHEN THE HCP (HEALTHCARE PROVIDER) TRIED TO SCREW ON THE 2 ADAPTOR ENDS. THE HCP WAS UNABLE TO DO SO BECAUSE THE SCREW THREAD WAS SEIZED (STUCK) AND THE PRODUCT WAS UNUSABLE. PERITONEAL CATHETER AND SOLUTE BAG WERE THE COMPONENTS BEING DISCONNECTED/CONNECTED AND THE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. EXCESSIVE FORCE WAS NOT USED ON THE PRODUCT AS THE DEVICE DID NOT WORK AT THE OPENING OF THE PACKAGING. THERE WAS NOTHING UNUSUAL OBSERVE ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK AND THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS DONE WITH NORMAL RESULT. TEGO WAS NOT UTILIZED. THE HCP USED ANOTHER ADAPTOR AS A REMEDIAL ACTION. THE PROCEDURE WAS PROCEEDED AND COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS REQUIRED. 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 18320073 ↗
• MalfunctionSep 6, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE STERILE PACKAGED ADAPTER WAS OPENED DURING A CATHETER PLACEMENT SURGICAL PROCEDURE BUT WOULD NOT FLUSH. A SECOND STERILE ADAPTER WAS AVAILABLE AND USED. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, ONLY ATTEMPTED TO FLUSH THE ADAPTER WITH STERILE NORMAL SALINE. IT WAS ALSO MENTIONED THAT THE DOCTOR REPORTED THE PROBLEM DURING THE SURGICAL PROCEDURE TO OR (OPERATING ROOM) NURSE WHO THEN REPORTED TO THE MANAGER. THERE WAS NOTHING UNUSUAL (NO VISIBLE ISSUE) OBSERVED ON THE ADAPTER PRIOR TO USE AND THERE WERE NO OBVIOUS DEFECTS FOUND ON THE DEVICE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE ONLY THE STANDARD STERILE IRRIGATION SYRINGE. THE CATHETER WAS FLUSHED WITHOUT DIFFICULTY WITH REPLACEMENT ADAPTER. THERE WAS NO REPORTED DIMENSION ISSUE. THE CUSTOMER DID NOT TRY TO REVERSE THE LINES. AN IDENTICAL ITEM REPLACEMENT WAS UTILIZED (PRODUCT WAS REPLACED) TO RESOLVE THE ISSUE. IT WAS ALSO MENTIONED THAT THE PATIENT WAS NOT AFFECTED BY THE NON-FLUSHING ADAPTER DURING CATHETER PLACEMENT, AS A REPLACEMENT WAS IMMEDIATELY AVAILABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695322 ↗
• MalfunctionAug 10, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE THREADED COVER OF THE TWO-PART TITANIUM ADAPTER DID NOT SCREW IN COMPLETELY TO THE ADAPTER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17499895 ↗
• MalfunctionJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, TWO SEPARATE TITANIUM ADAPTERS WERE OPENED AND ATTACHED TO THE CATHETER. THE TITANIUM ADAPTER WAS DETACHED, AND WHEN ATTEMPTED TO SCREW TOGETHER, IT WOULD NOT CLOSE COMPLETELY SO THAT IT WAS FLUSHED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS FINE WHEN PERFORMED PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE PRODUCT WAS REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE 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 17266825 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, 2 SEPARATE TITANIUM ADAPTERS WERE OPENED AND ATTACHED TO THE CATHETER ON THE SAME EVENT FOR THE SAME PATIENT. THE TITANIUM ADAPTER WAS DETACHED, AND WHEN ATTEMPTED TO SCREW TOGETHER, IT WOULD NOT CLOSE COMPLETELY SO THAT IT WAS FLUSHED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS FINE WHEN PERFORMED PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE PRODUCT WAS REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED DUE TO THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE 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 17260039 ↗
• MalfunctionJun 30, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, 2 SEIZED SCREW THREAD MAKE IT UNUSABLE. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 17238257 ↗
• InjuryMay 30, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE LAST COUPLE OF MONTHS, THE CUSTOMER REPORTED THAT THEY RECENTLY NOTICED THAT PERITONEAL DIALYSIS (PD) PATIENTS WHO HAD PERITONEAL DIALYSIS (PD) CATHETER PLACEMENT HAD THEIR TITANIUM ADAPTER DETACHED (CAME OFF). THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, AND THE IMPLANT SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING REPORTED FROM ANY OF THE AFFECTED PATIENTS IN ADVANCE. TITANIUM ADAPTERS WERE REPLACED ON ALL PATIENTS, THEY RECEIVED IP (INTRAPERITONEAL) ANTIBIOTICS, ONE DEVELOP POSITIVE GRAM STAIN GROWTH. TITANIUM ADAPTERS WERE REPLACED AND NEW TRANSFER SETS WERE APPLIED TO ALL.

  Patient problems: Bacterial Infection

  MAUDE report 17024103 ↗
• InjuryMay 30, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE LAST COUPLE OF MONTHS, THE CUSTOMER REPORTED THAT THEY RECENTLY NOTICED THAT PERITONEAL DIALYSIS (PD) PATIENTS WHO HAD PERITONEAL DIALYSIS (PD) CATHETER PLACEMENT HAD THEIR TITANIUM ADAPTER DETACHED (CAME OFF). THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, AND THE IMPLANT SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING REPORTED FROM ANY OF THE AFFECTED PATIENTS IN ADVANCE. TITANIUM ADAPTERS WERE REPLACED ON ALL PATIENTS, THEY RECEIVED IP (INTRAPERITONEAL) ANTIBIOTICS, ONE DEVELOP POSITIVE GRAM STAIN GROWTH. TITANIUM ADAPTERS WERE REPLACED AND NEW TRANSFER SETS WERE APPLIED TO ALL.

  Patient problems: Bacterial Infection

  MAUDE report 17023773 ↗
• InjuryMay 30, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE LAST COUPLE OF MONTHS, THE CUSTOMER REPORTED THAT THEY RECENTLY NOTICED THAT PERITONEAL DIALYSIS (PD) PATIENT WHO HAD PERITONEAL DIALYSIS (PD) CATHETER PLACEMENT HAD THEIR TITANIUM ADAPTER DETACHED (CAME OFF). THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE, AND THE IMPLANT SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. NOTHING REPORTED FROM ANY OF THE AFFECTED PATIENTS IN ADVANCE. TITANIUM ADAPTERS WERE REPLACED ON ALL PATIENTS, THEY RECEIVED IP (INTRAPERITONEAL) ANTIBIOTICS, ONE DEVELOP POSITIVE GRAM STAIN GROWTH. TITANIUM ADAPTERS WERE REPLACED AND NEW TRANSFER SETS WERE APPLIED TO ALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Bacterial Infection

  MAUDE report 17022277 ↗
• MalfunctionMay 26, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DOCTOR HAD STATED THAT THE 2 PART THREAD COULD NOT LONGER TWIST TOGETHER. THE PHYSICIAN HAD TO CUT THE ADAPTOR OFF AND HAD TO USE AN ALTERNATIVE CAP. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17015174 ↗
• MalfunctionApr 21, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2023, A PD (PERITONEAL DIALYSIS) CATHETER WAS INSERTED AND AN ADAPTER WAS CONNECTED TO THE PD CATHETER IN THE OR (OPERATING ROOM). POST-OP (POST-OPERATIVE) DRESSING OBSERVED TO HAVE BIOPATCH AT SITE AND WHOLE CATHETER INCLUDING TRANSFER SET COILED INSIDE COMPETITOR'S BRAND IV (INTRAVENOUS) DRESSING. DURING FIRST DRESSING CHANGE, ONE WEEK AFTER INSERTION, COVER OF TITANIUM ADAPTER WAS NOTED TO BE NOT COMPLETELY SCREWED INTO THE ADAPTER. AN ATTEMPT TO SCREW IN COMPLETELY WAS FUTILE. ADAPTER WAS OTHERWISE CONNECTED TO CATHETER AND TRANSFER SET PROPERLY, NO LEAK ANYWHERE ALONG THE CATHETER AND TRANSFER SET NOTED. THE COVER USED WAS THE ONE INCLUDED IN THE REPORTED TITANIUM ADAPTER KIT. NO OTHER DEFECTS/DAMAGES NOTED ON THE PRODUCT. NO DIMENSION ISSUE NOTED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO CLEANING AGENT USED ON THE DEVICE. THEY DISCUSSED IT WITH PHYSICIAN WHO STATED NO NEED TO TREAT AS CLOSED SYSTEM WAS MAINTAINED AND CATHETER REPAIR WOULD BE DONE USING STERILE TECHNIQUE. REPAIR OF PD CATHETER WAS DONE BY RN (REGISTERED NURSE). THE DEFECTIVE TITANIUM ADAPTER WAS REPLACED ON THE SAME DAY. THE NEW TITANIUM ADAPTER AND A TRANSFER S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788216 ↗
• MalfunctionMar 31, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, IN SURGERY AT THE TIME OF PLACEMENT, WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE ITEMS, TITANIUM LUER LOCK ADAPTERS WITH FIVE 2226500212 LOTS AND ONE 2218100129 LOT WERE CROSS THREADED AND WOULD NOT FULLY TWIST CLOSE OR INTERFACE PROPERLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO INSTRUMENTS WERE USED, THESE WERE HAND TIGHTENED. IT WAS ALSO STATED THAT IF THE VENDOR LISTED THE DIMENSIONS ON THE PACKAGE, THEIR PRODUCT CONTROL DEPARTMENT WAS MAKING CERTAIN THE DIMENSIONS MATCHED THE INFORMATION ON THE PACKAGING. NO ONE HAD THE TIME OR AVAILABLE TOOLS TO CHECK PRODUCTS IN SURGERY TO MEASURE DIMENSIONS. WHEN SAID DEVICE WOULD NOT PROPERLY CONNECT, THE TEAM SIMPLY OPENED MORE OF THE ITEM UNTIL ONE WAS FOUND THAT CONNECTED PROPERLY. REPLACEMENT PRODUCT HAD BEEN SHIPPED TO CUSTOMER AND THE REPLACEMENTS PROVIDED BY THE COMPANY WERE THE ONES USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658884 ↗
• MalfunctionMar 31, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, IN SURGERY AT THE TIME OF PLACEMENT, WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE ITEMS, TITANIUM LUER LOCK ADAPTERS WITH FIVE 2226500212 LOTS AND ONE 2218100129 LOT WERE CROSS THREADED AND WOULD NOT FULLY TWIST CLOSE OR INTERFACE PROPERLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO INSTRUMENTS WERE USED, THESE WERE HAND TIGHTENED. IT WAS ALSO STATED THAT IF THE VENDOR LISTED THE DIMENSIONS ON THE PACKAGE, THEIR PRODUCT CONTROL DEPARTMENT WAS MAKING CERTAIN THE DIMENSIONS MATCHED THE INFORMATION ON THE PACKAGING. NO ONE HAD THE TIME OR AVAILABLE TOOLS TO CHECK PRODUCTS IN SURGERY TO MEASURE DIMENSIONS. WHEN SAID DEVICE WOULD NOT PROPERLY CONNECT, THE TEAM SIMPLY OPENED MORE OF THE ITEM UNTIL ONE WAS FOUND THAT CONNECTED PROPERLY. REPLACEMENT PRODUCT HAD BEEN SHIPPED TO CUSTOMER AND THE REPLACEMENTS PROVIDED BY THE COMPANY WERE THE ONES USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658841 ↗
• MalfunctionMar 31, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, IN SURGERY AT THE TIME OF PLACEMENT, WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE ITEMS, TITANIUM LUER LOCK ADAPTERS WITH FIVE 2226500212 LOTS AND ONE 2218100129 LOT WERE CROSS THREADED AND WOULD NOT FULLY TWIST CLOSE OR INTERFACE PROPERLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO INSTRUMENTS WERE USED, THESE WERE HAND TIGHTENED. IT WAS ALSO STATED THAT IF THE VENDOR LISTED THE DIMENSIONS ON THE PACKAGE, THEIR PRODUCT CONTROL DEPARTMENT WAS MAKING CERTAIN THE DIMENSIONS MATCHED THE INFORMATION ON THE PACKAGING. NO ONE HAD THE TIME OR AVAILABLE TOOLS TO CHECK PRODUCTS IN SURGERY TO MEASURE DIMENSIONS. WHEN SAID DEVICE WOULD NOT PROPERLY CONNECT, THE TEAM SIMPLY OPENED MORE OF THE ITEM UNTIL ONE WAS FOUND THAT CONNECTED PROPERLY. REPLACEMENT PRODUCT HAD BEEN SHIPPED TO CUSTOMER AND THE REPLACEMENTS PROVIDED BY THE COMPANY WERE THE ONES USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657225 ↗
• MalfunctionMar 31, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, IN SURGERY AT THE TIME OF PLACEMENT, WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE ITEMS, TITANIUM LUER LOCK ADAPTERS WITH FIVE 2226500212 LOTS AND ONE 2218100129 LOT WERE CROSS THREADED AND WOULD NOT FULLY TWIST CLOSE OR INTERFACE PROPERLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO INSTRUMENTS WERE USED, THESE WERE HAND TIGHTENED. IT WAS ALSO STATED THAT IF THE VENDOR LISTED THE DIMENSIONS ON THE PACKAGE, THEIR PRODUCT CONTROL DEPARTMENT WAS MAKING CERTAIN THE DIMENSIONS MATCHED THE INFORMATION ON THE PACKAGING. NO ONE HAD THE TIME OR AVAILABLE TOOLS TO CHECK PRODUCTS IN SURGERY TO MEASURE DIMENSIONS. WHEN SAID DEVICE WOULD NOT PROPERLY CONNECT, THE TEAM SIMPLY OPENED MORE OF THE ITEM UNTIL ONE WAS FOUND THAT CONNECTED PROPERLY. REPLACEMENT PRODUCT HAD BEEN SHIPPED TO CUSTOMER AND THE REPLACEMENTS PROVIDED BY THE COMPANY WERE THE ONES USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657224 ↗
• MalfunctionMar 31, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, IN SURGERY AT THE TIME OF PLACEMENT, WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE ITEMS, TITANIUM LUER LOCK ADAPTERS WITH FIVE 2226500212 LOTS AND ONE 2218100129 LOT WERE CROSS THREADED AND WOULD NOT FULLY TWIST CLOSE OR INTERFACE PROPERLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO INSTRUMENTS WERE USED, THESE WERE HAND TIGHTENED. IT WAS ALSO STATED THAT IF THE VENDOR LISTED THE DIMENSIONS ON THE PACKAGE, THEIR PRODUCT CONTROL DEPARTMENT WAS MAKING CERTAIN THE DIMENSIONS MATCHED THE INFORMATION ON THE PACKAGING. NO ONE HAD THE TIME OR AVAILABLE TOOLS TO CHECK PRODUCTS IN SURGERY TO MEASURE DIMENSIONS. WHEN SAID DEVICE WOULD NOT PROPERLY CONNECT, THE TEAM SIMPLY OPENED MORE OF THE ITEM UNTIL ONE WAS FOUND THAT CONNECTED PROPERLY. REPLACEMENT PRODUCT HAD BEEN SHIPPED TO CUSTOMER AND THE REPLACEMENTS PROVIDED BY THE COMPANY WERE THE ONES USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657163 ↗
• MalfunctionMar 31, 2023Defective Component; Connection Problem; Defective Component; Connection Problem

  ACCORDING TO THE REPORTER, IN SURGERY AT THE TIME OF PLACEMENT, WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE ITEMS, TITANIUM LUER LOCK ADAPTERS WITH FIVE 2226500212 LOTS AND ONE 2218100129 LOT WERE CROSS THREADED AND WOULD NOT FULLY TWIST CLOSE OR INTERFACE PROPERLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. NO CLEANING USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NO INSTRUMENTS WERE USED, THESE WERE HAND TIGHTENED. IT WAS ALSO STATED THAT IF THE VENDOR LISTED THE DIMENSIONS ON THE PACKAGE, THEIR PRODUCT CONTROL DEPARTMENT WAS MAKING CERTAIN THE DIMENSIONS MATCHED THE INFORMATION ON THE PACKAGING. NO ONE HAD THE TIME OR AVAILABLE TOOLS TO CHECK PRODUCTS IN SURGERY TO MEASURE DIMENSIONS. WHEN SAID DEVICE WOULD NOT PROPERLY CONNECT, THE TEAM SIMPLY OPENED MORE OF THE ITEM UNTIL ONE WAS FOUND THAT CONNECTED PROPERLY. REPLACEMENT PRODUCT HAD BEEN SHIPPED TO CUSTOMER AND THE REPLACEMENTS PROVIDED BY THE COMPANY WERE THE ONES USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657156 ↗
• MalfunctionMar 3, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TITANIUM ADAPTOR PIECES WERE NOT TWISTING TOGETHER AS EASY AS THEY SHOULD. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED WITH NORMAL RESULT. THE DEVICE WAS REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THEY USED ANOTHER CONNECTION PIECE OR ADAPTER AS THE REMEDIAL ACTION DONE TO ADDRESS THE ISSUE AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS SUCCESSFULLY USED AND THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 16482077 ↗
• MalfunctionFeb 9, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE ADAPTER DID NOT SCREW ONTO THE CATHETER AFTER MANY ATTEMPTS (THE USER WAS NOT ABLE TO PLACE THE ADAPTER TO THE PERITONEAL DIALYSIS CATHETER). THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE ADAPTER WAS NOT TIGHTENED/LOOSENED BY HANDS OR BY INSTRUMENTS BECAUSE THE USER AND STAFF COULD NOT CONNECT THE PRODUCTS WITH THEIR HANDS AND TOOLS. FLUSHING WAS NOT PERFORMED. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE BECAUSE ALL PRODUCTS CAME FROM THE KIT. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE PRODUCT. A NEW ADAPTER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343632 ↗
• MalfunctionFeb 2, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TITANIUM ADAPTER WAS DEFECTIVE (DEVICE WAS HARD TO USE). THE PATIENT WAS BROUGHT IN BY THE PARENTS FOR TRANSFER SET CHANGE AFTER THE PATIENT TOOK OFF THE MINI CAP. PRIOR TO TRANSFER SET CHANGE, A WEAK SPOT WAS OBSERVED AT THE TITANIUM ADAPTER AND DECISION WAS MADE TO REPAIR THE PD (PERITONEAL) CATHETER WHICH WAS MADE BY THE REGISTERED NURSE. THE THREADED COVER OF THE FIRST TITANIUM ADAPTER WAS APPLIED BUT IT DID NOT SCREW IN COMPLETELY TO ADAPTER. A WHOLE NEW STERILE SET UP WITH A NEW TITANIUM ADAPTER WAS OBTAINED. WHEN THE SECOND ADAPTER WAS APPLIED, THREADED COVER ALSO DID NOT SCREW IN COMPLETELY TO ADAPTER. A NEW SETUP WAS OBTAINED AGAIN, AND PLASTIC ADAPTER WAS APPLIED THIS TIME. THERE WAS NO ISSUE NOTED WITH PLASTIC ADAPTER. DUE TO MULTIPLE MANIPULATION OF THE CATHETER, DECISION WAS MADE BY THE DOCTOR AND NURSE TO TREAT THE PATIENT PROPHYLACTICALLY WITH INTRAPERITONEAL CEFAZOLIN. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16286047 ↗
• MalfunctionFeb 2, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, AT THE TIME OF INSERTION, THE TWO PART TITANIUM CONNECTOR WOULD NOT THREAD CORRECTLY ON THE PD (PERITONEAL DIALYSIS) CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS TREATED WITH CHLORAPREP PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO ISSUE WITH THE PD CATHETER. NOTHING WAS VISUALLY WRONG WITH THE ADAPTER. FLUSHING WAS NORMAL. THE METHOD UTILIZED TO TIGHTEN THE ADAPTER WAS BY HAND. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE DIMENSION OF THE DEVICE MATCHED WHAT WAS INDICATED ON THE LABEL. NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THE PRODUCT WAS REPLACED WITH THE SWAN NECK 62.5CM CURL CATHETER LEFT (DIFFERENT PRODUCT ID OR IDENTIFIER), IT WAS BEING PLACED IN PATIENT, THEY USED THE BETA CAP ADAPTER INCLUDED WITH CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. 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 16283997 ↗
• MalfunctionJan 24, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TWO-PART TITANIUM ADAPTER WAS SUPPOSED TO THREAD TOGETHER BUT THE DEVICE WAS DEFECTIVE AND WOULD NOT THREAD PROPERLY AT ALL. IT WAS ALSO STATED THAT, INSTEAD OF USING THE TITANIUM ADAPTER, THEY HAD TO USE THE LESS DURABLE PLASTIC ADAPTER THAT COMES WITH THE CATHETER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THE DEVICE WAS PAIRED WITH A PD (PERITONEAL DIALYSIS) CATHETER BUT IT WAS UNRELATED TO THE EVENT (SEPARATE ITEM). FLUSHING WAS PERFORMED WITH NO ISSUE RESULT. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, THERE WAS NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED, THE LUER ADAPTER DID NOT THREAD/SPIN/ATTACH, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE DEVICE WAS REPLACED THE SAME DAY WITH THE SAME PRODUCT ID AND LOT NUMBER AS THE REMEDIAL ACTION DONE. THE PROCEDURE WAS PROCEEDED AND COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS THE RESULT OF THE 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 16233337 ↗
• MalfunctionJan 23, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE CONNECTOR DID NOT CLOSE CORRECTLY. THE CATHETER WAS REPAIRED, 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 PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228610 ↗