Bard® Urine Meter Foley Catheter Tray With Bard® Hydrophilic-Coated Foley 800365Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741020124), received between Nov 22, 2019 and Nov 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY LEAKED WHERE THE DRAINAGE TUBING MEETS THE DRAINAGE BAG. IT WAS STATED THAT IT APPEARED IT MAY HAVE BECOME UNBONDED CREATING A LEAK AND OPEN SYSTEM. THE FOLEY WAS REMOVED AND THE PATIENT WAS PUT ON THE PUREWICK SYSTEM.

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

  MAUDE report 9364732 ↗