SureStep™ Foley Tray System Bard® Lubricath Foley A800366Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741073977), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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.

• MalfunctionDec 6, 2017Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DRAIN BAG WOULD NOT ALLOW URINE TO DRAIN FROM THE CATHETER INTO THE BAG CAUSING DISCOMFORT. THE COMPLAINANT ALLEGED THAT ONCE THE DRAIN BAG TUBING WAS MANIPULATED, 400ML OF URINE WAS DRAINED FROM PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 7087019 ↗