Argyle 8888413419Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521004603), received between Feb 21, 2018 and Feb 7, 2024 — classified as 1 injury, 2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Break; Break

  ACCORDING TO THE REPORTER, THEY CALLED THE PERITONEAL DIALYSIS DEPARTMENT FROM A PATIENT FOLLOWED FROM HOME CONCERNING A LEAK IN THE PERITONEAL DIALYSIS CATHETER BECAUSE THE PATIENT FOUND THE BED "ALL WET" ON AT 9AM. THEY ASKED THE PATIENT TO COME IN FOR A CONSULTATION TO CHECK THE PROBLEM AND REPAIR THE CATHETER IF NECESSARY, BEARING IN MIND THAT PATIENT WAS LIVING MORE THAN 1 HOUR FROM THE HOSPITAL. WHEN THE PATIENT ARRIVED, FIRST HAD TO REMOVE THE TAPE WRAPPED AROUND THE CATHETER, WHICH HAD BEEN USED TO SEAL THE HOLE AND ALSO ROLLED IT UP UNDER A BANDAGE SO THAT IT WOULD NOT WANDER OUT OF CLOTHES. THE PATIENT SHOWED ROUGHLY WHERE THE HOLE WAS. ONCE THE PLASTER HAD BEEN REMOVED, THE HOLE COULD BE SEEN AT THE END OF THE GREY TIP WHICH WAS A PART OF THE CATHETER AND WHICH CONNECTED TO THE EXTENSION LINE. IT WOULD APPEAR THAT THE CUT WAS DUE TO THE RIGIDITY OF THE ADAPTER TIP, WHICH HAD DAMAGED THE CATHETER TUBING WHEN IT WAS BEING HANDLED (POSSIBLE TWISTING). THIS EVENT HAD THE FOLLOWING CONSEQUENCES: MAJOR RISK OF INFECTION, WITH HOSPITAL TREATMENT DUE TO THE IMPOSSIBILITY OF USING THE CATHETER AS IT WAS AND THEREFORE THE FOLLOWING: CYTOLOGY ON THE DIALYSATE PRESENT IN THE PERITON

  Patient problems: Insufficient Information

  MAUDE report 18664564 ↗
• InjurySep 18, 2023Break; Migration; Break; Migration

  ACCORDING TO THE REPORTER, THE PATIENT WAS BROUGHT BACK BECAUSE THE PATIENT¿S CATHETER WAS CRACKED IN HALF IN THE PATIENT¿S ABDOMEN. AFTER THE SURGICAL INTERVENTION, POST-OPERATIVE X-RAY SHOWED THAT THE CATHETER WAS CUT INTO TWO. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE COMPLICATIONS ASSOCIATED WITH THE ISSUE WERE THAT THE CATHETER HAD MIGRATED UP THE RIGHT SIDE OF THE ABDOMEN, RESULTING IN A LACK OF DRAINAGE. THE CATHETER WAS REPLACED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17770163 ↗
• MalfunctionFeb 21, 2018Break; Break

  ACCORDING TO THE REPORTER, LEAKAGE WAS OBSERVED WHEN THE CATHETER WAS RINSED AFTER PLACEMENT. THE CATHETER SHOWED A VERTICAL CUT. NO CLINICAL CONSEQUENCES REPORTED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286055 ↗