Argyle 8888423103Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521055933), received between Jan 30, 2018 and Oct 15, 2025 — classified as 7 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PERITONEAL DIALYSIS CATHETER PLACEMENT SURGERY WAS PERFORMED. THE EXTERNAL PACKAGING OF THE CATHETER AND ACCESSORIES WAS INTACT, BUT PREOPERATIVE EXAMINATION REVEALED SEPARATION/DETACHMENT OF THE CUFF FROM THE CATHETER ON THE PERITONEAL DIALYSIS CATHETER AND ACCESSORIES. IT WAS ALSO MENTIONED THAT SOMETHING UNUSUAL HAD BEEN OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AN EXCESSIVE FORCE USE ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION, A NEW PERITONEAL DIALYSIS CATHETER WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 23278025 ↗
• MalfunctionAug 18, 2025Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, A HOLE WAS OBSERVED AT THE CUFF OF THE PERITONEAL DIALYSIS CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834204 ↗
• MalfunctionAug 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING PERITONEAL DIALYSIS CATHETERIZATION SURGERY, AFTER THE PERITONEAL DIALYSIS CATHETER AND ACCESSORIES WERE OPENED, THE SURGEON CHECKED THE INTEGRITY OF THE CATHETER AND FOUND A 0.1 CM (CENTIMETER) CRACK IN THE MIDDLE OF THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 22745455 ↗
• MalfunctionAug 7, 2025Break; Break

  ACCORDING TO THE REPORTER, THE OUTER PACKAGING OF THE PRODUCT WAS NOT DAMAGED. HOWEVER THE TUBE INSIDE WAS BROKEN. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737392 ↗
• MalfunctionJun 18, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT PERITONEAL DIALYSIS CATHETER PLACEMENT ON (B)(6) 2025. INTRAOPERATIVE AND POSTOPERATIVE EXAMINATIONS REVEALED NO LEAKS IN THE PERITONEAL DIALYSIS CATHETER. ON THE DAY OF THE EVENT, AT 9:00 AM, DURING THE DRESSING CHANGE OF THE ABDOMINAL SURGICAL SITE, A LEAK WAS OBSERVED AT THE TITANIUM CONNECTOR OF THE PERITONEAL DIALYSIS CATHETER APPROXIMATELY 0.5 CM FROM THE CONNECTION POINT. THIS LEAK POSED A RISK OF SEVERE INFECTIONS SUCH AS PERITONITIS AND COULD COMPROMISE DIALYSIS EFFICACY. IMMEDIATE MEASURES INCLUDED CLAMPING THE TUNNEL EXIT OF THE PERITONEAL CATHETER WITH A BLUE CLAMP, FOLLOWED BY ANTISEPTIC FLUSHING WITH POVIDONE-IODINE SOLUTION. THE TITANIUM CONNECTOR AND THE SHORT PERITONEAL DIALYSIS CATHETER WERE REPLACED. THE PATIENT WAS ADMINISTERED ORAL LEVOFLOXACIN FOR THREE DAYS FOR INFECTION PROPHYLAXIS. ROUTINE ANALYSIS AND CULTURE OF THE PERITONEAL DIALYSIS EFFLUENT WERE PERFORMED, WITH NO SIGNS OF FEVER, ABDOMINAL PAIN, OR OTHER DISCOMFORT OBSERVED. A CRACK WAS OBSERVED AT THE LUER ADAPTER. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284216 ↗
• MalfunctionMar 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE OPERATION, THERE WAS A LEAK AT THE CUFF DUE TO A FRACTURE. THERE WAS NO ISSUE WITH THE LUER ADAPTER. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT, AND SALINE WAS USED AS THE CLEANING AGENT FOR THE DEVICE. TEGO WAS NOT UTILIZED. NO ABNORMALITIES WERE OBSERVED ON THE DEVICE PRIOR TO USE, AND NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAKAGE WAS OBSERVED. THE REPORTER FLUSHED THE LUMEN BEFORE USE WITH NORMAL RESULTS. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE, AND IT WAS NOT USED WITH ANY OTHER PRODUCTS. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION, THE CATHETER WAS COMPLETELY EXPLANTED AND REPLACED WITH ANOTHER ONE OF THE SAME PRODUCT ID AND LOT ON THE DAY OF THE EVENT. THE PATIENT WAS TREATED WITH REGIONAL ANESTHESIA, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS PERFORMED. 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 21662683 ↗
• MalfunctionMar 19, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE CATHETER WAS NOT YET IMPLANTED, IT WAS OBSERVED THAT THE CATHETER HAD A TINY CRACK. THERE WAS NOTHING UNUSUAL ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE REPORTED PRODUCT WAS REPLACED AS A REMEDIAL ACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642095 ↗
• MalfunctionJan 28, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER OPENING, THE SURGEON CHECKED THE INTEGRITY OF THE CATHETER AND FOUND A 0.1 CENTIMETER CRACK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT REPAIRED. NOTHING ELSE UNUSUAL WAS FOUND ON THE DEVICE PRIOR TO USE. NO DAMAGE WAS FOUND TO THE STERILE BARRIER (INNER PACKAGING). NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. NO DAMAGE TO THE OUTER PACKAGING (BOX) WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252072 ↗
• MalfunctionNov 11, 2024Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT HAD BEEN UNDERGOING PERITONEAL DIALYSIS FOR MORE THAN THREE YEARS DUE TO STAGE 5 CHRONIC KIDNEY DISEASE (CKD). THE PERITONEAL CATHETER WAS FOUND TO HAVE LIQUID LEAKAGE, AND THE PATIENT CAME TO THE HOSPITAL'S NEPHROLOGY DEPARTMENT FOR TREATMENT. AFTER EXAMINATION, A BROKEN POINT WAS FOUND ABOVE THE TITANIUM CONNECTOR OF THE PERITONEAL DIALYSIS CATHETER. THE CLAMPING SWITCH WAS RELEASED, AND THE PERITONEAL DIALYSIS FLUID FLOWED OUT OF THE BROKEN POINT IN A STRAIGHT LINE. THE PERITONEAL DIALYSIS CATHETER WAS CLAMPED IMMEDIATELY, AND THE TITANIUM CONNECTOR WAS REMOVED FROM THE PERITONEAL DIALYSIS CATHETER. THE PERITONEAL DIALYSIS CATHETER WITH THE BROKEN POINT WAS CUT OFF FROM THE BOTTOM OF THE PERITONEAL DIALYSIS CATHETER TO THE TOP, ABOUT 1 CENTIMETER LONG WHERE THE RUPTURE POINT, AND CONTINUED TO BE USED. THE TITANIUM CONNECTOR WAS SOAKED IN IODINE FOR HALF AN HOUR FOR DISINFECTION AND THEN RECONNECTED TO THE PERITONEAL DIALYSIS CATHETER, AND A SHORT TUBE WAS CONNECTED EXTERNALLY. THEY INFORMED THE PATIENT OF PRECAUTIONS. IF THE LIQUID LEAKAGE WAS NOT HANDLED IN TIME, IT WOULD CAUSE ABDOMINAL INFECTION IN THE PATIENT. IF THE INFECTION WOULD BE

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

  MAUDE report 20652485 ↗
• MalfunctionOct 7, 2024Break; Connection Problem; Break; Connection Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL AS AN OUTPATIENT DUE TO ELEVATED CREATININE FOR 7 YEARS, WORSENING WITH GENERAL FATIGUE FOR 20 DAYS. ON (B)(6) 2023, PERITONEAL DIALYSIS ABDOMINAL CAVITY CATHETERIZATION WAS PERFORMED UNDER LOCAL ANESTHESIA, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2024. IT WAS STATED THAT AFTER DISCHARGE, THE PATIENT RECEIVED THE PERITONEAL DIALYSIS TREATMENT AT HOME. ON THE DAY OF THE EVENT, DURING DIALYSIS, FLUID LEAKAGE WAS FOUND IN THE PERITONEAL DIALYSIS CATHETER AND ACCESSORIES AT THE TITANIUM CONNECTOR. ON (B)(6) 2024, THE PATIENT CAME TO THE HOSPITAL TO SEE A DOCTOR FOR TREATMENT. THE TITANIUM CONNECTOR WAS REMOVED, CUT OFF A PART OF THE SHORT TUBE THAT LEAKED FLUID, AND RECONNECTED IT AFTER DISINFECTION. NO ADVERSE CONSEQUENCES OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382947 ↗
• InjuryJun 1, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER THE SURGERY, THE PATIENT UNDERWENT LONG-TERM PERITONEAL DIALYSIS AT HOME. ON (B)(6) 2024, LEAKAGE FROM THE PERITONEAL DIALYSIS CATHETER WAS DISCOVERED, RESULTING IN HOSPITALIZATION. THE INITIAL JUDGEMENT WAS THAT IT WAS CAUSED BY WEAR OF THE CATHETER. THERE WAS NO TITANIUM CONNECTOR ISSUE. THE PATIENT ADMITTED TO THE HOSPITAL RELATED TO THIS REPORTED EVENT ON (B)(6), 2024. IT WAS ALSO STATED THAT THE CAUSE OF THE EVENT WAS THAT THERE MIGHT BE REPEATED FOLDING DURING OPERATIONS, RESULTING IN REPEATED FRICTION BETWEEN THE CATHETER AND THE TITANIUM CONNECTOR. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT 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. THE CLEANING AGENT WAS NOT ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT(S) TO THE AREA. THE CLEANING AGENT NEVER SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENTS NEVER MIXED. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THE SITE NEVER USED SEPSIDERM TO CLEAN CATHETERS. THERE WAS NO PROTOCOL CHANGE FOR CLEANING AGENTS USED RECENTLY. THE PATIENT THEMSE

  Patient problems: Insufficient Information

  MAUDE report 19442760 ↗
• MalfunctionApr 15, 2024Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PATIENT WAS UNDERGOING PERITONEAL DIALYSIS TUBE PLACEMENT, IT WAS DISCOVERED DURING INSPECTION OF SUPPLIES (BEFORE ACTUAL PLACEMENT OF THE CATHETER) AND WHEN THE PRODUCT WAS FLUSHED THAT THE FRONT END OF THE CATHETER WAS LEAKING WATER AND HAD RUPTURED OR CRACKED. NOTHING ELSE UNUSUAL WAS OBSERVED ON THE DEVICE. THE FRONT END OF THE CATHETER, WHICH WAS THE DAMAGED PART, WAS CUT OFF AS INTERVENTION REQUIRED AS A RESULT OF THE EVENT; THE TITANIUM CONNECTOR WAS MOVED FORWARD; THE EXTERNAL SHORT TUBE WAS CONNECTED; AND IT WAS REPORTED IN A TIMELY MANNER. THE PRODUCT OR DEVICE WAS STILL USED TO IMPLANT, THE PROCEDURE WAS COMPLETED, AND THE CATHETER WAS STILL INSIDE THE PATIENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105188 ↗
• MalfunctionDec 19, 2023Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING PERITONEAL DIALYSIS TREATMENT FOR CHRONIC KIDNEY DISEASE (CKD5), AT 15:00, THE PATIENT EXPERIENCED A RUPTURE AND LEAKAGE AT THE TITANIUM CONNECTOR OF THE PERITONEAL DIALYSIS TUBE. THE PERITONEAL DIALYSIS TUBE CONNECTING SHORT TUBE WAS REPLACED, AND CEFAZOLIN SODIUM WAS ADDED TO THE ABDOMINAL CAVITY TO PREVENT INFECTION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18357606 ↗
• InjuryNov 29, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, DURING PERITONEAL DIALYSIS, THE ULTRAFILTRATION VOLUME WAS LOW, WHICH WAS CONSIDERED AS A PERITONEAL ULTRAFILTRATION FUNCTION FAILURE, AND THE BLOOD PRESSURE CONTROL WAS NOT GOOD. IT WAS ALSO STATED THAT THE PERITONEAL DIALYSIS CATHETER MALFUNCTIONED. IT WAS RECOMMENDED TO CHANGE TO HEMODIALYSIS TREATMENT. ON (B)(6) 2023, THE PERITONEAL DIALYSIS (PD) CATHETER WAS MANUALLY REMOVED AS A PRELIMINARY ACTION. IT WAS STATED THAT IT WAS THE PATIENT'S PERITONITIS THAT LED TO THE EXTUBATION. THE REPORT WAS NOT THE ADVERSE EVENT OF THE PRODUCT, BUT THE PATIENT'S OWN IMPROPER OPERATION, WHICH LED TO PERITONITIS.

  Patient problems: Peritonitis

  MAUDE report 18225692 ↗
• MalfunctionSep 8, 2023Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2023, THE PATIENT UNDERWENT LAPAROSCOPIC PERITONEAL DIALYSIS CATHETERIZATION AND TREATED WITH LOCAL ANESTHESIA. AFTER THE CATHETER WAS IMPLANTED, THERE WAS LEAKAGE OF PERITONEAL DIALYSIS FLUID. A CRACK WAS FOUND ON THE CATHETER WHERE THE LEAK OBSERVED. THE POLYESTER SLEEVE INSIDE THE CATHETER WAS INSPECTED FOR RUPTURE. THERE WAS NO ADAPTER ISSUE. THE LUMENS WERE NOT FLUSHED PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THERE WAS NO UNUSUAL OBSERVED ON THE CATHETER PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE ON THE CATHETER. THE REPAIR KIT WAS NOT USED. DURING THE SURGERY, A NEW IMPLANT CATHETER WAS REPLACED DIRECTLY ON THE OPERATING TABLE AS INTERVENTION/TREATMENT PERFORMED. THE DRAINAGE OF THE PATIENT¿S POSTOPERATIVE DRAINAGE TUBE WAS UNOBSTRUCTED AND WITHOUT LEAKAGE. TREATMENT (LOTIONS/OINTMENTS, MEDICATIONS), OINTMENTS, WOUND DRESSINGS, SEPSIDERM AND CLEANING AGENTS WERE UNUSED DURING THE EVENT. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THE TREATMENT WAS COMPLETED. THERE WAS A VERY SMALL AMOUNT OF BLOOD LOSS (SUBMUSCULAR HEMORRHAGE), BUT BLOOD TRANSFUSION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714358 ↗
• InjuryJul 31, 2023Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT NEEDED PERITONEAL DIALYSIS DUE TO CHRONIC RENAL INSUFFICIENCY AND UREMIA. ON (B)(6) 2021, AFTER THE PD (PERITONEAL DIALYSIS) CATHETER WAS IMPLANTED IN THE NEPHROLOGY DEPARTMENT OF THE HOSPITAL, REGULAR PD TREATMENT WAS PERFORMED. TODAY, WHEN THE PATIENT WAS PERFORMING NORMAL PERITONEAL DIALYSIS FLUID REPLACEMENT AT HOME, IT WAS FOUND THAT THE DIALYSIS CATHETER WAS LEAKING LIQUID. A CAREFUL OBSERVATION REVEALED THAT THE PD CATHETER WAS RUPTURED AND THE DIALYSIS CATHETER WAS CLAMPED IMMEDIATELY WITH A CLIP. AFTER 20 MINUTES, THE PATIENT CAME TO THE HOSPITAL FOR CONSULTATION. THE DOCTOR FOUND THAT THERE WAS LEAKAGE ON THE UPPER END OF THE TITANIUM CONNECTOR WHICH WAS A LEAKAGE OF THE DIALYSIS TUBE. THE LEAKING PART WAS CUT OFF, DISINFECTED FOR HALF AN HOUR AND THE TITANIUM CONNECTOR WAS RECONNECTED. AFTER CONNECTED AND DISINFECTED FOR HALF AN HOUR, THE EXTERNAL SHORT TUBE WAS CONNECTED, IT COULD BE USED NORMALLY AND THE ISSUE WAS RESOLVED. IT WAS ALSO MENTIONED THAT PERSONAL HYGIENE WAS NOT OBSERVED AFTER THE DIALYSIS TUBE WAS BROKEN. THERE WAS NO CONNECTOR ISSUE AND NORMAL SALINE WAS THE CLEANING AGENT USED TO CLEAN THE CATHETER AND ITS ENTIRETY

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 17430561 ↗
• InjuryJul 11, 2023Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT PERITONEAL DIALYSIS CATHETERIZATION IN THE HOSPITAL ON (B)(6) 2021 DUE TO RENAL INSUFFICIENCY AND UREMIA, AND UNDERWENT LONG-TERM PERITONEAL DIALYSIS TREATMENT. ON THE MORNING OF (B)(6) 2023, THE PATIENT FOUND FLUID LEAKING FROM THE PERITONEAL DIALYSIS TUBE AT HOME. THREE HOURS LATER, THE PATIENT WAS CONSULTED BY THE NEPHROLOGY DEPARTMENT OF THE HOSPITAL AND THE DOCTOR FOUND THAT THERE WAS LEAKAGE AT THE UPPER END OF THE TITANIUM JOINT, WHICH BELONGED TO THE LEAKAGE OF THE DIALYSIS TUBE. THE PATIENT HAD A LOT OF PERITONEAL DIALYSATE EXTRAVASATION. IT WAS ALSO STATED THAT THE PATIENT WAS NOT PROTECTED WELL AT HOME AND THE PERITONEAL DIALYSIS TUBE WAS KINKED RESULTING IN DAMAGE TO THE DIALYSIS TUBE. THERE WAS NO ADAPTER ISSUE. NO EXCESSIVE FORCE APPLIED TO THE DEVICE. NOTHING UNUSUAL OBSERVED ON THE CATHETER PRIOR TO USE. FLUSHING WAS PERFORMED WITH SALINE PRIOR TO USE OF THE CATHETER AND THE RESULT WAS NORMAL. NO CRACK, CUT, OR HOLE FOUND ON THE CATHETER WHERE THE LEAK OBSERVED. NO OTHER PRODUCTS BEING UTILIZED WITH THE CATHETER. FORMAL MANUFACTURER WOUND DRESSINGS WAS UTILIZED. THE WOUND DRESSINGS DID NOT INCLUDE ANY CLEANING AGENTS

  Patient problems: Unspecified Infection

  MAUDE report 17301859 ↗
• MalfunctionJun 5, 2023Break; Connection Problem; Detachment of Device or Device Component; Break; Connection Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT PERITONEAL DIALYSIS CATHETERIZATION UNDER LOCAL ANESTHESIA IN THE OPERATING ROOM. TWO HOURS AFTER THE OPERATION, THE PATIENT RETURNED TO THE WARD AND FOUND THAT THE CLOTHES AND ABDOMINAL BAND WERE WET AND IT WAS NOTED THAT THERE WAS A LIQUID LEAK NEAR THE TITANIUM JOINT. AFTER CAREFUL OBSERVATION, THE PERITONEAL DIALYSIS TUBE WHERE THE LEAK WAS LOCATED WAS FOUND TO BE RUPTURED (HAD A CRACK). THE CATHETER WAS NOT REPAIRED. THERE WAS A CONNECTOR ISSUE AND TEGO WAS UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED WITH A CLEANING AGENT PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND HAD A NORMAL OUTCOME. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THE CATHETER WAS NOT REPLACED AND THEY WERE STILL WAITING FOR CATHETER PLACEMENT TO RESOLVE THE ISSUE. THE PATIENT DID NOT HAVE ANY INFECTION AND THERE WERE NO TESTS PERFORMED TO CONFIRM THE INFECTION. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT NEEDED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT PROVIDED TO THE PATIENT AS A RESULT OF THE EVENT. THE EVENT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060673 ↗
• MalfunctionDec 28, 2022Break; Break

  ACCORDING TO THE REPORTER, BEFORE THE SURGERY, THE TUBE BETWEEN THE TWO CUFFS OF THE PERITONEAL DIALYSIS WAS DAMAGED AND HAD A LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND 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 NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED AND THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060364 ↗
• InjuryDec 19, 2022Break; Connection Problem; Break; Connection Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS AT HOME, THE PATIENT FOUND THAT THE TOP OF THE TITANIUM CONNECTOR OF THE PERITONEAL DIALYSIS TUBE WAS DAMAGED. THE DAMAGED PART WAS IN THE SHAPE OF A ROUND HOLE WITH A DIAMETER OF ABOUT 1MM (MILLIMETER). THE PERITONEAL FLUID HAD LEAKED WHICH WOULD AFFECT THE DIALYSIS TREATMENT. THE PATIENT WENT TO THE OUTPATIENT CLINIC ON THE SAME DAY, AND NO CREASES WERE FOUND AT THE TITANIUM CONNECTOR AFTER INSPECTION. THE TUBE WAS CUT IMMEDIATELY, AND THE PERITONEAL DIALYSIS EXTERNAL SHORT TUBE WAS REPLACED. THE PATIENT WAS HOSPITALIZED FOR ANTI-INFECTION TREATMENT TO PREVENT THE OCCURRENCE OF PERITONITIS.

  Patient problems: Insufficient Information

  MAUDE report 16003931 ↗
• MalfunctionDec 19, 2022Break; Break

  ACCORDING TO THE REPORTER, AFTER AEROBICS AT HOME NOT IN TREATMENT, THE PATIENT FOUND THAT THE TOP OF THE TITANIUM CONNECTOR OF THE PERITONEAL DIALYSIS TUBE WAS DAMAGED (BROKEN). THE DAMAGED PART WAS IN THE SHAPE OF A ROUND HOLE WITH A DIAMETER OF ABOUT 1 MM. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CLEANING AGENT WAS NOT TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. NO OINTMENT AND WOUND DRESSING UTILIZED AT THE EXIT SITE. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENT ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING AND APPLYING OINTMENT TO THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. NO CLEANING AGENT EVER SWITCHED OVER THE LIFE OF THE CATHETER NOT EVER MIXED. THE SITE NOT EVER USE SEPSIDERM TO CLEAN CATHETERS. NO PROTOCOL CHANGE FOR CLEANING AGENTS USED RECENTLY. IT WAS SAID THAT THE TREATMENT (LOTIONS/OINTMENTS, MEDICATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003909 ↗
• MalfunctionDec 14, 2022Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PERITONEAL DIALYSIS WAS PERFORMED ON THE PATIENT, IT WAS FOUND THAT THERE WAS A LEAK OF WATER FROM THE DIALYSIS TUBE (AT THE BACK OF THE CUFF WHERE IT WAS EXPOSED OUTSIDE THE BODY). THE CATHETER WAS CHECKED BY THE DOCTOR AND NURSE, BUT THERE WAS NO SIGN OF SHARP OBJECT DAMAGED, AND THE TITANIUM CONNECTOR WAS ANASTOMOSED WITH THE CONNECTION OF THE CATHETER. THE PATIENT WAS NOT WEARING THE LEATHER BELT AND THE CATHETER WAS NOT BROKEN BACKWARDS. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND A HOLE WAS FOUND ON THE DEVICE WHERE THE LEAK WAS OBSERVED. IT WAS ALSO MENTIONED THAT FLUSHING WAS NOT PERFORMED, THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE BLUE CLIP DIALYSIS TUBE WAS CLAMPED, THE BROKEN END WAS CUT OFF AND THE CONNECTING TITANIUM JOINT WAS STERILIZED AS THE PRELIMINARY ACTION DONE. THE TREATMENT WAS COMPLETED, AND THE BLOOD OF THE PATIENT WAS SAFELY RETURNED. THE EVENT AFFECTED THE DIALYSIS AND THERE WAS A HIGH RISK OF INFECTION, BUT IT WAS CONFIRMED THAT THERE WAS NO INFECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982974 ↗
• MalfunctionNov 22, 2022Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PATIENT UNDERWENT PERITONEAL DIALYSIS TREATMENT AT HOME, WATER LEAKAGE OF THE TUBE NEAR THE PERI TONEAL DIALYSIS CONNECTOR WAS FOUND HALFWAY THROUGH THE INFUSION OF PERITONEAL DIALYSIS FLUID. THE PERITONEAL DIALYSIS TREATMENT WAS SUSPENDED IMMEDIATELY, THE PROXIMAL END WAS CLAMPED WITH A BLUE CLIP, AND THE PERITONEAL DIALYSIS CENTER WAS CALLED FOR HELP. THE P ERITONEAL DIALYSIS NURSE INSTRUCTED THE PATIENT TO RETURN TO THE OUTPATIENT CLINIC TO REPLACE THE PERITONEAL DIALYSIS CONNECTOR AND THE EXTERNAL SHORT TUBE ACCORDING TO THE PREVENTION AND CONTROL REGULATIONS. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15848875 ↗
• MalfunctionJul 18, 2022Break; Break

  ACCORDING TO THE REPORTER, BEFORE SURGERY, THE CATHETER WAS FOUND TO HAVE A CRACK NEAR THE CUFF. THE CATHETER WAS NOT REPAIRED, NO LEAK, NO CLEANING AGENT USED ON THE DEVICE, NO TEGO UTILIZED, AND NO LUER ADAPTER ISSUE. NO DAMAGE TO THE DEVICE¿S BOX. NO DAMAGE TO THE DEVICE¿S EXTERNAL OR INTERNAL PACKAGING. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT ON THE SAME DAY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047692 ↗
• MalfunctionFeb 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WAS A PARTIAL RUPTURE OF CUFF BODY OUTSIDE PERITONEAL DIALYSIS TUBE AND IT GOT SEPARATED FROM THE CATHETER. NO ABNORMAL PHENOMENA AND NO DAMAGED ON THE PACKAGING WAS NOTED PRIOR TO USE. THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE IMPLANTATION SITE WAS TREATED WITH IODOPHOR BEFORE IMPLANTATION. COMPETITOR'S EXTERNAL SHORT PIPE WAS UTILIZED WITH THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. ON THAT SAME DAY, THE BROKEN PART OF THE CATHETER WAS CUT AND WAS CONNECTED TO COMPETITOR'S EXTERNAL SHORT TUBE. THE BROKEN PART WAS THEN REPAIRED AND REPLACED WITH THE SAME LOT NUMBER (CATHETER WAS NOT REPAIRED USING COMPETITOR'S EXTERNAL SHORT TUBE, IT WAS JUST CONNECTED TO IT AFTER BEING CUT). PROCEDURE WAS THEN COMPLETED AND THE REMAINING PART STILL REMAINED IN THE PATIENT¿S BODY. THE FINAL PATIENT'S OUTCOME WAS STABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453660 ↗