Bard® Urine Meter Foley Catheter Tray With Bard® Lubri-Sil® Catheter 942208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741029370), received between Jun 28, 2017 and Sep 20, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 25, 2026Open, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3115-2026 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjurySep 20, 2024Material Rupture; Sharp Edges; Material Rupture; Sharp Edges

  IT WAS REPORTED THAT BARD FOLEY CATHETER TRAY 8FR PEDIATRIC KIT WAS USED FOR A ROUTINE VOIDING CYSTOURETHROGRAM UNDER FLUOROSCOPY. INSERTION WAS WITHOUT ISSUE AND FUNCTIONED CORRECTLY DURING THE EXAMINATION. FOLEY CATHETER BALLOON WAS APPROPRIATELY DEFLATED WITH REMOVAL OF AT LEAST 5 CC OF FLUID. DURING THE REMOVAL OF THE CATHETER, HOWEVER, SIGNIFICANT RESISTANCE WAS MET AT THE NAVICULAR FOSSA OR MEATUS PORTION. THE PATIENT WAS IN DISTRESS AS A RESULT. REINSERTION WAS ALSO MET WITH RESISTANCE. THE PEDIATRIC INTENSIVE CARE UNIT NURSING TEAM WHO FACILITATED THE PLACEMENT WAS CONSULTED AND THEY ALSO BECAME UNCOMFORTABLE WITH THE DEGREE OF RESISTANCE. CONTRAST WAS ADMINISTERED AND CONFIRMED IN IMAGING A NORMAL COURSE OF URETHRA AND WELL AS A DEFLATED BALLOON. THE UROLOGY TEAM WAS THEN CONSULTED WHO THEN REMOVED THE CATHETER AGAINST THE RESISTANCE. NO BLOOD OR TRAUMA WAS NOTED FOLLOWING THE REMOVAL. THE UROLOGY TEAM NOTED A DESIGN FLAW DISTAL TO THE FOLEY BALLOON IN WHICH THERE WERE PLASTIC PRONGS THAT WERE CAUGHT WITHIN THE URETHRA. THE PHYSICIAN AND THEM EXAMINED AN UNOPENED KIT DIFFERENT LOT FROM STOCK AND NOTED NO REPRODUCTION OF PRONGS DISTAL TO THE BALLOON. IT WAS UNKNOWN WHAT MED

  Patient problems: Distress

  MAUDE report 20266531 ↗
• MalfunctionJun 28, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKED URINE FROM THE TUBING, NEAR THE "HUB", BELOW THE BALLOON, FOR TWENTY SECONDS. SUBSEQUENTLY, THE DEVICE WAS REPLACED. THE NURSE REPORTED THAT THE PATIENT NEEDED A FOLEY CATHETER FOR CHEMOTHERAPY, AND ATIVAN WAS GIVEN PRIOR TO PLACING THE FOLEY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6675386 ↗