Argyle 8888412619Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521004450), received between Oct 2, 2019 and Apr 26, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Break; Break

  ACCORDING TO THE REPORTER, WHEN PATIENT ON DIALYSIS TREATMENT, THE NURSE FOUND A LEAKAGE OF DIALYSATE AT THE LEVEL OF THE EMERGENCE (EXIT) OF THE PD (PERITONEAL DIALYSIS) CATHETER. CLINICAL CONSEQUENCES WERE NON-OPTIMAL PD AND PATIENT WAS RESCHEDULED. AT THE MOMENT, NO ACTION OR PRECAUTIONARY MEASURES. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19191957 ↗
• InjuryAug 2, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, MORE THAN A MONTH AFTER CATHETER INSERTION, DURING USE, THE PHARMACIST REPORTED THAT THE PATIENT EXPERIENCED AN ABDOMINAL PAIN DUE TO THE INTRAPERITONEAL CATHETER. THERE WAS MEDICAL INTERVENTION REQUIRED.

  Patient problems: Abdominal Pain

  MAUDE report 12264147 ↗
• InjuryAug 4, 2020Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THERE WAS RECURRENCE OF HYPOGASTRIC PAIN EACH TIME THERE WERE AN ADMINISTRATION OF INTRAPERITONEAL PHYSIOLOGICAL SERUM VIA THE CATHETER, WITH AN ABDOMEN THAT REMAINED PERFECTLY FLEXIBLE, WITHOUT FEVER. THERE WAS NO MALPOSITION OF THE CATHETER. THE PATIENT LEFT THE HOSPITAL AND SINCE THEN THERE WAS NO RECURRENCE OF PAIN. FOUR (4) DAYS LATER, A NEW TEST AFTER PREMEDICATION OF WATER INJECTION AND RECURRENCE OF IMMEDIATE PAIN OCCURRED. SIGNIFICANT PAIN EXPERIENCED BY THE PATIENT AND NEEDED FOR RE-HOSPITALIZATION. THE HOSPITALIZATION FOR TREATMENT WAS INITIALLY PLANNED FOR 1 TO 2 DAYS AND WAS EXTENDED UP TO 3 DAYS (TOTAL OF 3 DAYS DURATION) FOR A NEW INJECTION ATTEMPT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. SODIUM CHLORIDE (NACL) WAS USED FOR FLUSHING PRIOR TO USE AS PROVIDED IN THE PROTOCOL AND NIVOLUMAB HAS NEVER BEEN INJECTED AND THE PAIN APPEARED DURING THE NACL RINSE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. ON THE SECOND DAY OF HOSPITALIZATION NEW ATTEMPT TO INJECT NACL WAS DONE AND HAD RECURRENCE OF PAIN AND THE RINSING WAS STOPPED. THE INFUSION WAS STOPPED WHEN THE PAIN APPEARED AND THE PAIN WAS RESOLVED SIMU

  Patient problems: Abdominal Pain

  MAUDE report 10362263 ↗
• MalfunctionOct 3, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS DIALYSATE LEAK THAT OCCURRED AT THE CATHETER LEVEL. THERE WAS A BREACH OBSERVED AT 1.5 CENTIMETERS FROM THE OUTSIDE OF THE CATHETER. IT WAS MENTIONED NO SCISSORS OR BANDAGE HAVE BEEN USED AND THAT THE IMPLANTATION WAS MORE THAN 60 MONTHS OLD. THEY HAD TO CHANGE THE EXTENSION OF THE CATHETER AND BETACAP AND AN INJECTION INTRA-PERITONEAL OF 2 GRAMS OF VANCOMYCINE IN PROPHYLAXIS WAS GIVEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151837 ↗
• MalfunctionOct 2, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DIALYSATE LEAKED AT THE CATHETER LEVEL/CONNECTION BETACAP LEVEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9148359 ↗
• MalfunctionOct 2, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A DIALYSATE LEAK THAT OCCURRED AT THE BETACAP LEVEL WITH A NET CUT AT THE CONNECTION (CATHETER/BETACAP). IT WAS MENTONED THAT THE IMPLANTATION WAS LESS THAN 60 MONTHS OLD. THE PATIENT HAD TO CHANGE THE EXTENSION LINE OF THE CATHETER AND BETACAP AND AN INJECTION INTRA-PERITONEAL OF 2 GRAMS OF VANCOMYCINE IN PROPHYLAXIS WAS GIVEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9148354 ↗