Bard® Urine Meter Foley Tray With Bardex® All-Silicone Foley Catheter 947516Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741025044), received between Jun 26, 2020 and Jun 26, 2020 — 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.

• MalfunctionJun 26, 2020Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT 2 HOURS AFTER THE FOLEY CATHETER WAS PLACED THERE WAS NO URINE IN THE DRAINAGE BAG. THE COMPLAINANT INSPECTED THE CATHETER AND FOUND THAT ONLY A SMALL AMOUNT OF URINE WAS PRESENT. THE NURSE REPORTEDLY PULLED THE CATHETER AND HAD MET NO RESISTANCE. IT WAS NOTED THAT WHEN THE CATHETER WAS REMOVED A PINHOLE WAS PRESENT IN THE BALLOON. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10199963 ↗