Bardex® I.C. Complete Care® Foley Tray 300016ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741000263), received between Nov 7, 2017 and Feb 12, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (1 report).

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 18, 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.

• MalfunctionFeb 12, 2018Restricted Flow rate; Improper or Incorrect Procedure or Method; Output Problem; Restricted Flow rate

  IT WAS REPORTED THAT THE URINARY DRAIN BAG WOULD NOT DRAIN PROPERLY. ALLEGEDLY, THE TUBE INSERT WAS NOT CUT PROPERLY, SUBSEQUENTLY URINE DID NOT FLOW INTO THE BAG.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7264243 ↗
• MalfunctionNov 7, 2017Corroded

  RN PLACED NEW FOLEY CATHETER. ONCE INSERTED AND BALLOON INFLATED, RN NOTICED THAT METAL CLIP THAT DRAINS URINE FROM THE COLLECTION BAG WAS RUSTED. THERE WAS NO MOISTURE NOTED IN THE INSERTION KIT. THE BAG WAS REPLACED WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7005956 ↗