Argyle 8888411405Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521054974), received between Nov 10, 2000 and Feb 11, 2026 — classified as 12 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, AT 6 PM, THE PATIENT FOUND THAT THE FABRIC COVERING THE CATHETER OUTLET WAS "WET," THE NURSE STATED THAT AFTER USE OF THE PRODUCT, THE CATHETER HAS BEEN DAMAGED AND LEAKED AT THE CATHETER SHAFT (JUNCTION OF THE BIFURCATE). THE REMEDIAL ACTION WAS THAT THE CATHETER WAS CLAMPED WITH A SMALL WHITE CLIP FIRST, AND PERITONEAL DIALYSIS WAS SUSPENDED AND WAS NOT COMPLETED. THE CATHETER WAS IN PLACE FOR ELEVEN YEARS AND FIVE MONTHS. ON (B)(6) 2025, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE THE NURSE FOUND A TEAR IN THE CATHETER DUE TO CATHETER DAMAGE. ON (B)(6) 2025, THE ANTIBIOTIC TREATMENT WAS CHANGED TO IV THERAPY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. TITANIUM METAL JOINT WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PATIENT WAS TREATED UNDER GENERAL ANESTHESIA. THE WOUND DRESSING WAS APPLIED WITH THE CATHETER EXIT SITE BEING CLEANED WITH NORMAL SALINE AND GENTAMICIN CREAM. THE WOUND DRESSING DOES NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY BEFORE THE DRESSING IS APPLIED TO THE AREA. THE CLEANIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313884 ↗
• InjuryFeb 11, 2026Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE PATIENT WAS TREATED FOR PERITONITIS WITH ANTIBIOTICS (CEFTAZIDIME 1 G IP QD, VANCOMYCIN 1 G IP ON TUESDAYS AND FRIDAYS) DUE TO DAMAGED CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Peritonitis

  MAUDE report 24313209 ↗
• InjuryNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT WAS FOUND TO BE DAMAGED AND HAD A LEAK ON THE SHAFT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THERE WERE NO IMPACTS AND NO ADVERSE EVENTS OR SYMPTOMS TO THE PATIENT. THE CLEANING AGENT USED ON THE CATHETER IN ITS ENTIRETY WAS NORMAL SALINE SOLUTION. GENTAMICIN WAS THE OINTMENT UTILIZED AT THE EXIT SITE. COVERING WITH REGULAR GAUZE WAS THE WOUND DRESSING UTILIZED. THERE WERE NO CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES INCLUDED IN THE WOUND DRESSING. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE PATIENT WAS RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THE CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENTS WERE NOT MIXED. SEPSIDERM WAS NOT USED TO CLEAN CATHETERS. THERE WAS NO PROTOCOL CHANGE USED FOR CLEANING AGENTS. THE PATIENT THEMSELVES USED AN ANTIBIOTIC (GENTAMICIN CREAM) ON THE CATHETER. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE

  Patient problems: Insufficient Information

  MAUDE report 23536648 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NURSE REPORTED THAT DURING USE IT WAS DISCOVERED THAT THE PRODUCT HAS NO CUFF. THE PERITONEAL DIALYSIS (PD) CATHETER IN THE PATIENT SHOULD NORMALLY HAVE AN EXTERNAL CUFF AND AN INTERNAL CUFF. THE INTERNAL CUFF WAS MISSING IN THE PATIENT, WHICH CAUSED THE CATHETER TO PROLAPSE DURING SLEEP AT NIGHT. THERE WERE NO ADVERSE EVENTS OR SYMPTOMS/IMPACTS. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO CLEANING AGENT WAS USED ON THE DEVICE. TWO YEARS EARLIER, THE CATHETER HAD BEEN EXAMINED IN THE OPERATING ROOM, AND NOTHING WAS UNUSUAL. AS A REMEDIAL ACTION, AFTER THE PD TUBE WAS REMOVED, HEMODIALYSIS WAS TEMPORARILY SWITCHED. THE CUFF WAS NOT FOUND WHEN REPLACED WITH A NEW CATHETER IN THE OPERATING ROOM. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE INTERVENTION/TREATMENT REQUIRED WAS TO CHANGE TO HEMODIALYSIS (HD) TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385177 ↗
• MalfunctionMar 19, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING USE, IT WAS FOUND THAT THE CATHETER WAS DAMAGED AND WAS LEAKING. IT WAS ALSO STATED THAT THE CATHETER HAD A CRACK. THERE WAS NO ISSUE WITH THE LUER ADAPTER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642224 ↗
• InjuryMar 14, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD THE CATHETER IMPLANTED ON (B)(6) 2015. IT WAS STATED THAT ON THE DAY OF THE EVENT, THE GAUZE COVERING THE OUTLET OF THE CATHETER WAS FOUND TO BE WET AT HOME. UPON RETURNING TO THE HOSPITAL AFTER USING THE REPORTED PRODUCT, THE CATHETER WAS FOUND TO BE DAMAGED, RESULTING IN LEAKAGE; THE PATIENT WAS IMMEDIATELY HOSPITALIZED FOR THREE DAYS FROM (B)(6) 2024, TO (B)(6) 2024, AND PD (PERITONEAL DIALYSIS) WAS IMMEDIATELY SUSPENDED. THE HOSPITALIZATION WAS A DIRECT RESULT OF THE PRODUCT-RELATED INCIDENT. ASIDE FROM THE ISSUE OF THE PRODUCT, IT WAS ALSO MENTIONED THAT THE CATHETER ALSO APPEARED MILKY WHITE AND OPAQUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE WOUND DRESSINGS THAT WERE UTILIZED WERE GAUZE AND FUSIDIC ACID CREAM. THE PATIENT WAS RESPONSIBLE FOR CATHETER MAINTENANCE. THE PATIENT WAS TREATED UNDER GENERAL ANESTHESIA. THE WOUND DRESSING DOES NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. ON (B)(6) 2024, THE CATHETER WAS REMOVED, AND AS A REMEDIAL ACTION, A NEW CATHETER WAS RE-IMPLANTED, AND AFTER

  Patient problems: Insufficient Information

  MAUDE report 21607466 ↗
• InjuryMar 13, 2025Break; Material Discolored; Break; Material Discolored

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE GAUZE COVERING THE OUTLET OF THE CATHETER WAS FOUND TO BE WET AT HOME. UPON RETURNING TO THE HOSPITAL FOR EXAMINATION, THE CATHETER WAS FOUND TO BE DAMAGED WITH A CRACK, WHICH LED TO LEAKAGE. IT WAS ALSO NOTED THAT THE AREA NEAR THE CATHETER EXIT APPEARED OPAQUE AND MILKY WHITE. THE PATIENT WAS IMMEDIATELY SCHEDULED FOR HOSPITALIZATION, AND PERITONEAL DIALYSIS (PD) WAS SUSPENDED. DURING THE REPLANTATION, THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS, FROM (B)(6) 2025, TO (B)(6) 2025. THERE WAS NO ISSUE WITH THE LUER ADAPTER, AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULTS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE CATHETER, AND NO EXCESSIVE FORCE WAS USED. NONALCOHOLIC POVIDONE-IODINE AND NORMAL SALINE WERE USED FOR DISINFECTION, WHILE STERILE GAUZE WAS USED AS THE WOUND DRESSING. THE WOUND DRESSING CONTAINED GENTAMICIN 0.1% CREAM, WHICH HAS CLEANING AGENT OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY BEFORE THE DRESSING WAS APPLIED AND BEFORE OINTMENTS WERE USED ON THE AREA. THE PATIENT WAS RESPONSIBLE FOR CATHETER MAINTENANCE. ON FEBRU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596581 ↗
• MalfunctionDec 27, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER USE FOR 5-6 MONTHS, THE TUBE NEAR THE ADAPTER WAS BROKEN/DAMAGED/LEAKING. THERE WAS NO ADAPTER ISSUE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. MUPIROCIN WAS UTILIZED AS AN OINTMENT AT THE EXIT SITE. THE PATIENT WAS GIVEN DRESSING CHANGES AT THE EXIT SITE ON AN IRREGULAR BASIS. THE SITE NEVER USED SEPSIDERM TO CLEAN CATHETERS. THE PATIENT WAS NOT USING ANY TYPE OF CLEANING AGENT, SPECIAL CLEANING, OR ANTIBIOTIC ON THE CATHETER. AFTER SHEARING, THE JOINT PART MOVED FORWARD AS REMEDIAL ACTION. THE PRODUCT WAS NOT REPLACED. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED DUE. TO THE EVENT. NO MEDICAL 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 21028261 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, BEFORE THE REMOVAL OF THE CATHETER, THE CUFF WAS FIRST FOUND TO BE LOOSE WITH THE CATHETER. FLUSHING WAS DONE PRIOR TO USE, AND THE CATHETER TEST WAS NORMAL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO OINTMENT(S) WERE UTILIZED AT THE EXIT SITE. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE PATIENT WAS RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE, AND THEY CLEANED WITH SALINE SOLUTION. THE SITE NEVER USED SEPSIDERM TO CLEAN CATHETERS. THE CATHETER HAD BEEN IN PLACED FOR 29 DAYS. THE CUFF WAS REMOVED IN THE OPERATING ROOM. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THE CATHETER PROBLEM WAS ADDRESSED BY SURGICAL MANAGEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943269 ↗
• InjuryAug 8, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THERAPY, THE CATHETER HAD INADEQUATE DRAINAGE. THE THERAPY WAS NOT COMPLETED. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING OR PRIMING DONE PRIOR TO USE HAD A NORMAL RESULT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. THE LINE WAS NOT HARD TO FLUSH WITH THE SYRINGE. THERE WAS NO BLOOD RETURN PRIOR TO THE SYRINGE FLUSH. NO ANTICOAGULANT (TPA, HEPARIN) WAS USED. NO OTHER MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS (THE DATE OF WHICH COULD NOT BE DETERMINED). MEDICATION WAS ADMINISTERED DURING HOSPITALIZATION. THE PATIENT WENT HOME. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19942855 ↗
• MalfunctionAug 7, 2024Break; Break

  ACCORDING TO THE REPORTER, A WEEK AFTER THE CUFF WAS REMOVED, LEAKAGE WAS FOUND AT THE CUFF REMOVAL SITE AT THE EXIT SITE OF THE CATHETER FROM THE PD (PERITONEAL DIALYSIS) TUBE SHAFT. FLUSHING WAS DONE PRIOR TO USE, AND THE CATHETER TEST WAS NORMAL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK OBSERVED. NO OINTMENT(S) WERE UTILIZED AT THE EXIT SITE. THEY WERE COVERED WITH STERILE GAUZE WHICH WAS A ROUTINE PROCEDURE. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE; THE PATIENT ONLY HAD THE CATHETER OUTLET CLEANED, AND IT WAS CLEANED WITH SALINE SOLUTION. THE SITE NEVER USED SEPSIDERM TO CLEAN CATHETERS. THE CATHETER HAD BEEN IN PLACED FOR 29 DAYS. THE PATIENT WAS RELUCTANT TO CONTINUE PD THERAPY BECAUSE OF THE CATHETER PROBLEM, SO THE PD CATHETER WAS REMOVED, AND THEY CHANGED TO HD (HEMODIALYSIS) THERAPY, WHICH SOLVED THE ISSUE. AFTER CHANGING THE TREATMENT MODE, THIS TREATMENT METHOD HAD BEEN USED FOR CONTINUOUS TREATMENT. THE TREATMENT WAS ABLE TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930932 ↗
• InjuryJul 22, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THERAPY, THE CATHETER HAD INADEQUATE DRAINAGE. THE THERAPY WAS NOT COMPLETED. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING OR PRIMING DONE PRIOR TO USE HAD A NORMAL RESULT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. THE LINE WAS NOT HARD TO FLUSH WITH THE SYRINGE. THERE WAS NO BLOOD RETURN PRIOR TO THE SYRINGE FLUSH. NO ANTICOAGULANT (TPA, HEPARIN) WAS USED. NO OTHER MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS (THE DATE OF WHICH COULD NOT BE DETERMINED). MEDICATION WAS ADMINISTERED DURING HOSPITALIZATION. THE PATIENT WENT HOME. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19802433 ↗
• InjuryJul 22, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING THERAPY, THE CATHETER HAD INADEQUATE DRAINAGE. THE THERAPY WAS NOT COMPLETED. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING OR PRIMING DONE PRIOR TO USE HAD A NORMAL RESULT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. THE LINE WAS NOT HARD TO FLUSH WITH THE SYRINGE. THERE WAS NO BLOOD RETURN PRIOR TO THE SYRINGE FLUSH. NO ANTICOAGULANT (TPA, HEPARIN) WAS USED. NO OTHER MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS (THE DATE OF WHICH COULD NOT BE DETERMINED). DURING THE HOSPITALIZATION, THE PATIENT WAS GIVEN SOFT STOOL AGENTS (STOOL SOFTENER LIQUID GELS FOR GENTLE AND SOFTENING RELIEF) FOR TREATMENT. THE PATIENT WENT HOME. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19800325 ↗
• InjuryJun 19, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THE NURSE STATED THAT THE PATIENT HAD A CATHETER IMPLANTED ON (B)(6) 2024. AFTER THE CATHETER WAS IMPLANTED, THE INJECTION WAS SMOOTH BUT THE DRAINAGE WAS NOT SMOOTH SO THE PATIENT WAS ADMITTED TO THE HOSPITAL, BUT IT NEVER IMPROVED. THE CATHETER WAS NOT REPAIRED. NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THE SITE NEVER USED SEPSIDERM TO CLEAN CATHETER. NO OINTMENT(S) UTILIZED AT THE EXIT SITE. NO WOUND DRESSING(S) UTILIZED. NO TREATMENT (LOTIONS/OINTMENTS, MEDICATIONS) BY PRESCRIPTION OR OVER-THE-COUNTER (OTC) USED.

  Patient problems: Insufficient Information

  MAUDE report 19571052 ↗
• InjuryJun 19, 2024Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PATIENT'S CATHETER WAS EXAMINED AT THE HOSPITAL, AND IT WAS FOUND THAT THE CATHETER WAS SERIOUSLY DISPLACED. THE PATIENT WAS ACTIVELY REQUESTED TO CHANGE TO HEMODIALYSIS AND ARRANGED FOR SURGICAL REMOVAL OF THE CATHETER. THE NEXT DAY, DURING REMOVAL, IT WAS FOUND THAT THE CATHETER WAS BROKEN IN THE ABDOMINAL CAVITY. THE CATHETER WAS NOT REPAIRED, AND THERE WAS A LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. THE SITE NEVER USED SEPSIDERM TO CLEAN THE CATHETER. NO OINTMENT(S) WERE UTILIZED AT THE EXIT SITE. NO WOUND DRESSING(S) WERE UTILIZED. IT WAS ALSO STATED THAT LAPAROSCOPIC SURGERY WAS DONE TO RESOLVE THE BROKEN CATHETER IN THE ABDOMEN. THE PATIENT REQUIRED AN X-RAY AS PART OF THE ORIGINAL PROCEDURE FOR THE REMOVAL OF THE CATHETER. ALL PARTS OF THE CATHETER WERE REMOVED, AND THE PROCEDURE WAS COMPLETED. THE ANESTHETIC TIME WAS NOT EXTENDED BY 30 MINUTES OR GREATER. AFTER THE CATHETER WAS REMOVED, TH

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19571050 ↗
• InjuryJun 19, 2024Break; Migration; Break; Migration

  ACCORDING TO THE REPORTER, THE NURSE REPORTED THAT THE PRODUCT WAS IMPLANTED ON THE PATIENT ON (B)(6) 2024. THE PATIENT WAS TEMPORARILY DISCHARGED FROM THE HOSPITAL FOR A FEW DAYS AFTER THE FIRST CATHETER IMPLANTATION. HOWEVER AFTER IMPLANTATION, THE PATIENT WAS HOSPITALIZED BECAUSE OF ABDOMINAL PAIN CAUSED BY THE INFUSION OF MEDICINE AND COULD NOT FEEL RELIEVED, AND IT HAD NOT IMPROVED AFTER THIS PATIENT ENGAGED MEDICAL TREATMENT. ON (B)(6) 2024, DUE TO THE DISPLACEMENT OF THE CATHETER, SURGERY WAS ARRANGED TO REMOVE THE CATHETER FROM THE PATIENT AND IT WAS FOUND THAT THE CATHETER HAD BEEN BROKEN IN THE ABDOMINAL CAVITY AFTER THE DIALYSIS. THERE WAS LEAK. THIS ISSUE CAUSED DRAINAGE NOT SMOOTH. THE PATIENT WAS HOSPITALIZED AGAIN BECAUSE OF THE RUPTURE OF THE INTRA-ABDOMINAL CATHETER. NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE TECHNIQUE USED TO REMOVE THE CATHETER WAS LAPAROSCOPIC SURGERY. THE PATIENT REQUIRED AN X-RAY. ALL PARTS OF THE CATHETER WERE REMOVED AND THE PR

  Patient problems: Abdominal Pain; Foreign Body In Patient; Pain; Unintended Radiation Exposure

  MAUDE report 19571048 ↗
• MalfunctionFeb 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING TREATMENT, THERE WAS A FLUID LEAKAGE AT THE CATHETER END NEAR THE TITANIUM JOINT DUE TO A HOLE FOUND IN IT. IT WAS MENTIONED THAT OCCURRENCE PLACE WAS IN SICKROOM DURING USE. SALINE SOLUTION WAS THE CLEANING AGENT USED ON THE DEVICE AND USED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. FLUSHING WAS NOT PERFORMED. AFTER THE ISSUE, THE DEFECTIVE CATHETER WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. WHILE THE REPORTER DID NOT MENTION THE TITANIUM JOINT WAS CHANGED AND THE HOLE AREAS WAS CUT. AFTER REPLACEMENT, TREATMENT CONTINUED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738200 ↗
• MalfunctionNov 29, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE BEFORE THE TREATMENT, THE NURSE REPORTED THAT THE PATIENT NOTICED THAT ONE UNIT OF THE CATHETER HAD A BREAKING HOLE AND HAD A LEAK ON THE TUBE NEAR THE TITANIUM (METAL) ADAPTER AFTER TAKING A BATH AT HOME ON THE DAY OF THE EVENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE WITH AN ABNORMAL RESULT DUE TO THE REPORTED HOLE, AND THERE WAS NO LEAK DURING FLUSHING. TEGO WAS NOT UTILIZED, AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WERE NO PRESCRIPTION OR OVER-THE-COUNTER LOTIONS, OINTMENTS, OR MEDICATIONS USED. THERE WAS NO OINTMENT USED AT THE EXIT SITE, AND THERE WAS NO WOUND DRESSING UTILIZED. THE SITE DID NOT USE SEPSIDERM TO CLEAN THE CA THETERS. THERE WAS NO PROTOCOL CHANGE FOR THE CLEANING AGENTS USED RECENTLY, AND THE CLEANING AGENTS WERE NEVER MIXED. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE, AND THE PATIENT DID NOT USE ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON THE CATHETER. TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234310 ↗
• InjuryNov 29, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD LEAK DUE TO DAMAGE. IN 2022, NURSE FOUND THAT THE PRODUCT WAS DEFORMED AND OPAQUE. AT THIS TIME, THERE WERE NO OTHER ABNORMALITIES OR LEAKAGE, AND THE NURSE DID NOT RULE OUT THE DEFORMATION CAUSED BY THE PATIENT'S POSSIBLE FOLDING INTO THE TUBE. PERITONITIS HOSPITALIZATION ALSO DID NOT TREAT THE TUBE, BECAUSE THERE WAS A LEAKAGE SITUATION BEFORE RETURNING TO THE HOSPITAL TO CUT OFF. ON (B)(6) 2023, THE PATIENT DEVELOPED PERITONITIS AND WAS ADMINISTERED VANCOMYCIN + FORTUM IP (CEFTAZIDIME INTRAPERITONEAL). ON (B)(6) 2023, THE LEAK WAS OCCURRED ON THE CATHETER DUE TO DAMAGE. ASIDE FROM THE ISSUE, IT WAS SAID THAT THERE WAS CATHETER DEFORMATION (EXTERNAL DEFORMATION, INTERNAL WHITE CIRCLE). THERE WERE NO PRODUCTS BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE USED ON THE PRODUCT. THERE WAS NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED. IODINE WAS USED AS CLEANING AGENT TO CLEAN THE EXIT SIDE AND TO DISINFECT THE SITE AFTER FLUSHING. AFTER THAT, GENTAMICIN CREAM WAS APPLIED TO KEEP THE AREA DRY. ON (B)(6), THE PATIENT WAS RETURNED TO THE HOSPITAL FOR TREATMENT. THE CATHETER WAS REPAIRED. AS REMEDIAL ACTION, THE OLD TUBE WAS CUT

  Patient problems: Peritonitis

  MAUDE report 18225655 ↗
• MalfunctionOct 10, 2022Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT IMPLANTED THE TUBE ON (B)(6) 2014. DURING TREATMENT AT THE HOSPITAL CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS) ROOM, A DAMAGE/CRACK (ABNORMAL) WITH A PD (PERITONEAL DIALYSIS) SOLUTION LEAKAGE FROM THE CATHETER SHAFT WERE IDENTIFIED. THE CIRCUIT WAS SIGNIFICANTLY THICK AND THIN AND WAS DAMAGED IN THE MIDDLE OF THE TITANIUM CONNECTOR AND PATIENT EXIT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO TREATMENT. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THEY FOLLOWED THE INSTRUCTION FROM THE FACILITY ABOUT THE CLEANING AGENT USED ON THE DEVICE AND SALINE WAS TYPICALLY UTILIZED TO CLEAN THE CATHETER AND ITS ENTIRETY. THE CLEANING AGENT WAS ALLOWED TO DRY PRIOR TO DRESSING THE AREA. NO OINTMENT WAS USED IN THE AREA AND AT THE EXIT SITE AND NO WOUND DRESSING WAS UTILIZED. NO HEATING WAS REQUIRED. THE PATIENT WAS RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE (CLEANING, DRESSING CHANGES, ETC.) SUCH AS IF THE CATHETER WAS DIRTY, THE PATIENT USED A NORMAL SALINE TO CLEAN (WIPE) IT, THEN KEEP IT DRY. THE CLEANING AGENT WAS NOT EVER SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENT WAS NEVER MIXED. THE SITE NEVER USE SEPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572682 ↗
• InjuryJan 21, 2022Break; Break

  ACCORDING TO THE REPORTER, THE 2 CUFF 41CM CATHETER WORKED WELL AFTER IMPLANTED FOR ONE AND A HALF MONTH, HOWEVER, WHEN THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) FOR OTHER DISEASES, THEY FOUND THAT THE PATIENT'S DRAINAGE WAS NOT SMOOTH SEVERAL DAYS LATER. THEREFORE, X-RAY EXAMINATION WAS ARRANGED AND FOUND THAT CATHETER WAS BROKEN (BROKE INTO THREE PIECES AS SHOWN ON THE PICTURE) AND INSIDE THE PATIENT'S ABDOMINAL CAVITY. PATIENT WAS SENT TO THE OPERATION ROOM ON (B)(6) 2021 TO REMOVE THE BROKEN CATHETER. THE CATHETER WAS NOT REPAIRED, TEGO WAS NO UTILIZED, NO LEAK AND NO LUER ADAPTER ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 13324343 ↗
• MalfunctionSep 2, 2021Break; Break

  ACCORDING TO THE REPORTER, AFTER IMPLANTING THE TUBE IN THE OPERATING ROOM, IT WAS DISCOVERED THAT THE CATHETER WAS DAMAGED AND LEAKING IN THE RECOVERY ROOM. THE LEAK WAS FOUND CLOSE TO THE TITANIUM METAL CONNECTOR. IT WAS STATED THAT THEY CUT THE LEAKING SECTION AND REPLACED IT WITH A TITANIUM METAL JOINT AND INFUSION TUBE AND THIS RESOLVED THE ISSUE AND DEVICE WAS USED SUCCESSFULLY. A TROCAR WAS USED WITH THE DEVICE FOR IMPLANT, THE DAMAGED PART WAS RIGHT AFTER THE TROCAR, AND THEY TOOK THIS AS A PRODUCT DEFECT SINCE THE AREA IS LESS LIKELY TO BE DAMAGED BY THE TROCAR. IT WAS STATED THAT NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO IMPLANTING. THE DOCTOR SAID THAT THERE WAS NO PROBLEM OF CLIP OR KNIFE SCRATCHING. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO BLOOD LOSS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND HAS CONTINUED ORAL PROPHYLACTIC ANTIBIOTICS. THERE WAS NO PROLONGED HOSPITALIZATION DUE TO ADVERSE EVENTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418845 ↗
• MalfunctionFeb 13, 2020Break; Break

  ACCORDING TO THE REPORTER, THE DOCTOR PERFORMED IMPLANTATION OF THE CATHETER AND THERE WAS FLUID LEAKAGE WHEN THE DOCTOR PULLED OUT THE CATHETER AND TRIED TO USE IT. THERE WAS NO DAMAGE TO THE PRODUCT BUT THEY FOUND ONE OF THE DACRON WAS IN THE WRONG PLACE AND THE DOCTOR FELT THAT IT WAS DIFFICULT TO PULL OUT THE CATHETER. IT WAS MENTIONED THAT THE PATIENT HAD A THICK FAT LAYER. THE PATIENT FOLLOWED THE INSTRUCTIONS FROM THE HOSPITAL WHEN CLEANING AND DRESSING THE CATHETER AND EXIT SITE (CLEANING AGENTS, OINTMENTS, WOUND DRESSINGS UTILIZED). THEY HAD TO REPLACE THE PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO BLOOD LOSS AND THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE LEAKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707334 ↗
• MalfunctionDec 4, 2019Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT'S PD (PERITONEAL DIALYSIS) CATHETER HAD A LEAKAGE AND DEGRADATION AT THE SHAFT OF TUBING (IT BECAME THIN AND TITANIUM ADAPTER WAS DETACHED AND HAD A LEAKAGE. THE NURSE CUT THE DEGRADED TUBING SHAFT AND RETURNED IT FOR EVALUATION). THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAKAGE AT THE JUNCTION OF THE BIFURCATE. TEGO WAS NOT UTILIZED AND THERE WERE NO LUER ADAPTER ISSUE. IT WAS ALSO STATED THAT THE PATIENT WAS RESPONSIBLE FOR THE DEVICE MAINTENANCE WHICH IT FOLLOW THE GENERAL CARE INSTRUCTION PROVIDE BY THE FACILITY AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407787 ↗
• MalfunctionFeb 5, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, DURING USE, IT WAS FOUND THAT THE CUFF APPEARED TO BE OUT F THE IMPLANT SITE. IT WAS ALSO FOUND THAT THE CUFF SLIDES (VELVET AN GLUE DETACHED) AND THE GLUE WAS LESS COMPARED TO BEFORE. IT WAS ALSO STATED THAT IMPLANT PREVIOUSLY HAD AN INFECTION AND THERE WERE CONCERN THERE WAS DAMAGE TO THE TUBING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304902 ↗