Argyle 8888111132Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521196087), received between Apr 10, 2018 and Apr 11, 2018 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE CATHETER HAD BEEN PLACED. THE INSERTION SITE WAS TREATED WITH CHLORAPREP AND LOBAN PRIOR TO PLACEMENT. AT THE POST OP VISIT, THE INSERTION AND EXIT SITES WERE NOTED TO HAVE ERYTHEMA AND PURULENT DRAINAGE. THE PATIENT WAS STARTED ON ORAL BACTRIM AND THE CATHETER WAS SCHEDULED FOR REMOVAL. IT WAS STATED THAT INTRAOPERATIVE, THERE WAS NO PURULENT DRAINAGE IN THE ABDOMINAL CAVITY, SO THE EXIT SITE OF THE CATHETER WAS CHANGED AND THE EXTERNAL PORTION OF THE CATHETER WAS CHANGED AS WELL.

  Patient problems: Unspecified Infection

  MAUDE report 7421008 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON POST OP VISIT, THE INSERTION SITE AND EXIT SITES WERE NOTED TO HAVE ERYTHEMA AND PURULENT DRAINAGE. THE PATIENT WAS STARTED ON PO BACTRIM FOR INFECTION AND HAD TO RETURN TO SURGERY FOR CATHETER REMOVAL. IT WAS ALSO REPORTED THAT THE INSERTION SITE WAS TREATED WITH CHLORAPREP AND LOBAN PRIOR TO THE PRODUCT PLACEMENT. THE PRODUCT WAS IMPLANTED BUT WAS THEN REMOVED AFTER MORE THAN A WEEK.

  Patient problems: Unspecified Infection

  MAUDE report 7419722 ↗