SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray A899616Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741104534), received between Oct 24, 2019 and Feb 26, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gel 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

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

   Z-3114-2026 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionFeb 26, 2020Material Discolored; Gel Leak; Short Fill; Gel Leak

  IT WAS REPORTED THAT THE SYRINGE WAS SHORT FILLED, AND WAS DARK YELLOW AND THICK.

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

  MAUDE report 9757093 ↗
• MalfunctionOct 24, 2019Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  IT WAS REPORT THAT A BETADINE SWAB STICK FROM A FOLEY PREP KIT WAS LEFT IN A PATIENT POST SURGERY. AT THE START OF A SURGERY, AN OR NURSE WAS PREPARING TO INSERT A FOLEY CATHETER INTO AN OBESE FEMALE PATIENT. THE NURSE REPORTED DIFFICULTY VISUALIZING THE URETHRA. AFTER THE NURSE PREPPED THE SITE, SHE PLACED ONE OF THE BETADINE PREP SWABS INTO THE PATIENT'S VAGINA TO ACT AS A LANDMARK. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGE HOME. POST OPERATION DAY ONE, THE PATIENT CALL THE POST OPERATIVE UNIT COMPLAINING OF SOME VAGINAL PRESSURE. THEN, WHILE SHE WAS URINATING SHE PULLED A SMALL HARD PLASTIC PIECE OUT OF HER VAGINA. THE PATIENT WAS INSTRUCTED TO GO TO HER PHYSICIANS OFFICE. IT WAS DETERMINED THAT THE ITEM REMOVED WAS A BETADINE SWAB STICK FROM A FOLEY PREP KIT . THE PATIENT WAS NOT INJURED. UPON THE INVESTIGATION BY THE HOSPITAL IT WAS DISCOVERED THAT THIS WAS A COMMON PRACTICE AMONG NURSES EVEN THOUGH IT WAS NOT THE INTENDED USE OF THE BETADINE PREP SWAB IN THE FOLEY KIT. THE FACILITY WANTED TO ALERT THE MANUFACTURE TO CONSIDER PUTTING A WARNING LABEL ON PACKAGE OR ALTER THE DESIGN OF THE PREP STICK TO PREVENT IT FROM BEING PLACED IN THE VAGINA.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; No Consequences Or Impact To Patient

  MAUDE report 9233325 ↗