Bard® Urine Meter Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 903216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741029226), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionSep 11, 2020Fluid/Blood Leak; Leak/Splash; Defective Component; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DRAIN BAG LEAKED. IT WAS LATER REPORTED FROM THE CUSTOMER ON (B)(6) 2020, THE LEAK WAS EXACTLY AROUND THE CATHETER. THE LEAK WAS FOUND 3-4 HOURS, AFTER THE USE AND 3 DEVICES WERE FOUND DEFECTIVE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10525728 ↗