Bard® Urine Meter Foley Catheter Tray With Bardex® Lubricath® Foley Catheter 902914Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741024856), received between Apr 25, 2017 and Mar 24, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE ICU STATED THAT THE CATHETER WAS CLOGGED. THEY STATED THAT THERE WAS A SMALL AMOUNT OF SEDIMENT THAT SHOULD NOT HAVE BEEN ENOUGH TO CLOG THE CATHETER.

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

  MAUDE report 9874289 ↗
• MalfunctionJul 19, 2017Leak/Splash; Device Slipped; Component Missing

  IT WAS REPORTED THAT THE CAP OF THE LUBRICATION SYRINGE CAME OFF AND THE LUBRICANT LEAKED THROUGHOUT THE TRAY MAKING IT UNUSABLE. PER THE SAMPLE EVALUATION, IT WAS NOTICED THAT THE SYRINGE CAP WAS MISSING FROM THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727223 ↗
• MalfunctionApr 25, 2017Fluid/Blood Leak; Device Damaged Prior to Use; Device Packaging Compromised

  IT WAS REPORTED THAT UPON OPENING THE TRAY, IT WAS NOTED THAT THE BETADINE LEAKED INSIDE OF THE TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6520617 ↗