Bard® Urine Meter Foley Tray With Bardex® Lubricath® Foley Catheter 942616Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741024832), received between Mar 14, 2019 and Mar 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Invagination” (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.

• MalfunctionMar 14, 2019Material Invagination; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS MET WITH RESISTANCE UPON REMOVAL. THE BALLOON WAS REPORTEDLY DEFLATED AND THE PATIENT EXPERIENCED PAIN AND BLEEDING AT THE MEATUS. WHEN THE CATHETER WAS REMOVED, THE BALLOON WAS NOTED TO HAVE FOLDED IN ON ITSELF, ¿CREATING A RIVET LIKE APPEARANCE.¿ THE BALLOON WAS REPORTEDLY INFLATED AND DEFLATED TO OBSERVE THE SAME FOLDING IN ACTION. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Patient Problem/Medical Problem

  MAUDE report 8420908 ↗