Argyle 8888425710Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521056022), received between Sep 23, 2020 and Jan 10, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Break; Break

  ACCORDING TO THE REPORTER DURING TREATMENT, AROUND EIGHT MONTHS AFTER THE CATHETER WAS IMPLANTED, THE CATHETER WAS FOUND WITH A HOLE ON THE INSIDE OF THE ABDOMEN, WHICH NOT CAUSED BY EXTERNAL FACTORS. THERE WAS A LEAK, AND THERE WERE NO OTHER DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. OINTMENTS WERE NOT USED AT THE EXIT SITE; COMPRESSES WERE THE WOUND DRESSING BEING UTILIZED, WHICH DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE PATIENT WAS RESPONSIBLE FOR THE MAINTENANCE OF THE CATHETER BY CHANGING THE DRESSING REGULARLY. THERE WERE NO CLEANING AGENTS OR ANTIBIOTICS THAT THE PATIENT USED THEMSELVES ON THE CATHETERS. IT WAS ALSO STATED THAT THE HOLE WAS IN THE SUBCUTANEOUS AREA OF THE CATHETER AND COULD NOT BE REPAIRED. AS A RESULT, THE PATIENT HAD TO UNDERGO SURGERY AND WAS ADMITTED ED FOR AN INPATIENT STAY FROM (B)(6)2024 TO (B)(6)2024 (EIGHT DAYS). THE CATHETER WAS EXPLANTED, AND A NEW CATHETER WITH A DIFFERENT LOT AND PRODUCT ID WAS INSERTED ON THE SAME DAY. SINCE THE PATIENT WAS UNABLE TO START PERITONEAL DIALYSIS IMMEDIATELY, A TUNNELED ATRIAL CATH

  Patient problems: Insufficient Information

  MAUDE report 21129901 ↗
• InjuryFeb 26, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED A PD (PERITONEAL DIALYSIS) CATHETER AND SHOWED SIGNS OF INFECTION. THE SIGNS WERE THERE BEFORE USING THE PD SOLUTIONS. THE CATHETER WAS STILL IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11387108 ↗
• InjurySep 23, 2020Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON (B)(6), A SMALL BEND WITH A HOLE IN THE TUNNEL AREA BETWEEN TWO SLEEVES WAS NOTED AND A LEAK WAS FOUND NEXT TO THE CUFF. THE CATHETER WAS EXPLANTED FROM THE LEFT SIDE AND A NEW CATHETER WAS IMPLANTED ON THE RIGHT AND THE TREATMENT FOR THE PERITONITIS CONTINUED TILL (B)(6) 2020. THE PATIENT WAS TRAINED TO CHANGE THE BANDAGES 2-3 DAYS (AFTER SHOWERING) DRY USING NORMAL WOUND COMPRESSES ¿CUTISOFT¿( 100% COTTON 7.5CM X 7.5CM) OR WITH 0.9% NACL THEN OCTENISEPT ALCOHOL-FREE OR GENTAMYCIN EYE DROPS LOCALLY AS THE CLEANING AGENTS USED EVERY DAY IF THERE ARE INFECTIONS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT AND DRESSING THE AREA. THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE OF THE LIFE OF THE CATHETER AND WAS NOT MIXED. NO "SEPSIDERM" WAS USED. THE CATHETER WAS NOT REPAIRED, NO TEGO UTILIZED, NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. THE PATIENT WAS CURRENTLY STABLE.

  Patient problems: No Consequences Or Impact To Patient; Peritonitis; Unspecified Infection

  MAUDE report 10577559 ↗
• InjurySep 23, 2020Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RECURRENCE OF PERITONITIS ON (B)(6) 2020 AND WAS AGAIN ADMITTED IN THE HOSPITAL UNTIL (B)(6). IT WAS STATED THAT THE BANDAGE WAS NOTED SOAKED ON (B)(6) AND (B)(6). THE PATIENT WAS TREATED WITH VANCOMYCIN (LIQUID FORM) INCORPORATED IN THE DIALYSATE DURING DIALYSIS. BLOOD GLUCOSE STICK TEST WAS DONE, AND THE RESULT WAS VERY HIGH (OVER 500MG/DL) WHICH MEANS THAT DIALYSATE WAS COMING OUT (SUSPECTED CATHETER LEAK). ON AUGUST 20TH, A SMALL BEND WITH A HOLE IN THE TUNNEL AREA BETWEEN TWO SLEEVES WAS NOTED AND A LEAK WAS FOUND NEXT TO THE CUFF. THE CATHETER WAS EXPLANTED (LEFT SIDE) ON (B)(6) AND A LEAK WAS FOUND NEXT TO THE CUFF. A NEW CATHETER WAS IMPLANTED ON THE RIGHT SIDE ON THE SAME DAY. THE PATIENT WAS TRAINED TO CHANGE THE BANDAGES 2-3 DAYS (AFTER SHOWERING) DRY USING NORMAL WOUND COMPRESSES ¿CUTISOFT¿( 100% COTTON 7.5CM X 7.5CM) OR WITH 0.9% NACL THEN OCTENISEPT ALCOHOL-FREE OR GENTAMYCIN EYE DROPS LOCALLY AS THE CLEANING AGENTS USED EVERY DAY IF THERE ARE INFECTIONS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT AND DRESSING THE AREA. THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE OF THE LIFE OF THE CAT

  Patient problems: Peritonitis; Unspecified Infection

  MAUDE report 10577544 ↗
• InjurySep 23, 2020Break; Break

  ACCORDING TO THE REPORTER, IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT CALLED CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS) AMBULANCE IN THE HOSPITAL FROM HOME AND SAID THE "PLASTER IS WET". TUNNEL INFECTION WAS TREATED WITH GENTAMICIN EYE DROPS LOCALLY. PATIENT WAS REPORTED TO BE HOSPITALIZED FROM ON (B)(6) 2020 DUE TO THE TUNNEL INFECTION. THE PATIENT WAS TRAINED TO CHANGE THE BANDAGES 2-3 DAYS (AFTER SHOWERING) DRY USING NORMAL WOUND COMPRESSES ¿CUTISOFT¿( 100% COTTON 7.5CM X 7.5CM) OR WITH 0.9% NACL THEN OCTENISEPT ALCOHOL-FREE OR GENTAMICIN EYE DROPS LOCALLY AS THE CLEANING AGENTS WERE USED EVERY DAY IF THERE ARE INFECTIONS. LOTIONS OR OINTMENTS USED WERE THROUGH PRESCRIPTION EXCEPT 0.9% NACI. WOUND DRESSING DID NOT INCLUDE ANY ANTIMICROBIAL PROPERTIES AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT AND DRESSING THE AREA. THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE SPAN OF THE CATHETER AND WAS NOT MIXED. NO SEPSIDERM WAS USED AND NO PROTOCOL CHANGES WAS USED IN CLEANING THE DEVICE. CHLRORATREP WAS THE INSERTION SITE (SKIN) TREATMENT PRIOR TO PRODUCT PLACEMENT FOR BOTH CATHETERS. OCTENISEPT ALCOHOL-FREE WAS USED AS THE CLEANING AGEN

  Patient problems: Unspecified Infection

  MAUDE report 10577407 ↗
• InjurySep 23, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED (B)(6) 2018. IT WAS REPORTED THAT PATIENT HAD PERITONITIS AND EXIT SITE INFECTION ON (B)(6) 2020. THE PATIENT WAS HOSPITALIZED, TUNNEL INFECTION WAS TREATED WITH GENTAMYCIN 80 MILLIGRAM EYE DROPS LOCALLY OVER TWO DAYS AND THEN WITH VANCOMYCIN UNTIL THE (B)(6). THE PATIENT WAS TRAINED TO CHANGE THE BANDAGES 2-3 DAYS (AFTER SHOWERING) DRY USING NORMAL WOUND COMPRESSES ¿CUTISOFT¿( 100% COTTON 7.5CM X 7.5CM) OR WITH 0.9% NACL THEN OCTENISEPT ALCOHOL-FREE OR GENTAMYCIN EYE DROPS LOCALLY AS THE CLEANING AGENTS USED EVERY DAY IF THERE ARE INFECTIONS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT AND DRESSING THE AREA. THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE OF THE LIFE OF THE CATHETER AND WAS NOT MIXED. NO SEPSIDERM WAS USED. THE CATHETER WAS NOT REPAIRED, NO TEGO UTILIZED, NO OTHER PRODUCTS BEING UTILIZED WITH T HE DEVICE AND NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. PATIENT'S CURRENT STATUS WAS STABLE.

  Patient problems: Peritonitis; Unspecified Infection

  MAUDE report 10575372 ↗
• InjurySep 23, 2020Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, IT WAS REPORTED THAT THE PATIENT HAD PERITONITIS ON (B)(6) 2020, AND THE FOLLOWING DAY A TUNNEL INFECTION WAS DETECTED BY ULTRASOUND. IT WAS STATED THAT THE PERITONITIS WAS TREATED WITH GENTAMYCIN ANTIBIOTIC AS A "SINGLE SHOT¿, VANCOMYCIN ANTIBIOTIC (3 WEEKS), AND GENTAMYCIN EYE DROPS LOCALLY WERE ADMINISTERED FOR THE TUNNEL INFECTION. THERE WAS A HOLE IN THE PD CATHETER AFTER 4 YEARS PERITONEAL DIALYSIS HOLE IN THE AREA OF THE TUNNEL. THIS HAS RESULTED IN PERITONITIS AND ON TUNNEL INFECTION. PAUSE OF THE DIAYLSIS PROCESS BECAME NECESSARY, AND A NEW OPERATION FOR IMPLANTATION OF A NEW CATHETER. PATIENT WAS REPORTED TO BE HOSPITALIZED FROM (B)(6) 2020 DUE TO THE PERITONITIS. THE PATIENT WAS TRAINED TO CHANGE THE BANDAGES 2-3 DAYS (AFTER SHOWERING) DRY USING NORMAL WOUND COMPRESSES ¿CUTISOFT¿( 100% COTTON 7.5CM X 7.5CM) OR WITH 0.9% NACL THEN OCTENISEPT ALCOHOL-FREE OR GENTAMYCIN EYE DROPS LOCALLY AS THE CLEANING AGENTS USED EVERY DAY IF THERE ARE INFECTIONS. LOTIONS OR OINTMENTS USED WERE THROUGH PRESCRIPTION EXCEPT 0.9% NACI. WOUND DRESSING DID NOT INCLUDE ANY ANTIMICROBIAL PROPERTIES, AND THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING

  Patient problems: Peritonitis; Unspecified Infection

  MAUDE report 10575343 ↗