SureStep™ Foley Tray System Bard® Lubricath® Foley Catheter Tray A800062Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741104411), received between Oct 16, 2022 and Oct 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryOct 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE NURSING STAFF OF THE HOSPITAL REPORTED FAILURES IN THE CLOSED SYSTEM OF VESICAL CATHETERIZATION. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, IT WAS REPORTED THAT THE FOLEY BLADDER CATHETERIZATION KITS DID NOT WORK PROPERLY. THE BED URINE BAG ONLY DRAINS IF IT WAS PLACED ON THE FLOOR AND THE USER¿S SKIN WAS INJURED WHEN REMOVING THE BRA THAT COMES WITH THE EQUIPMENT DESPITE THE FACT THAT THE PROTECTOR USED IN THE SKIN AND CAREFULLY REMOVED IT. IT WAS MENTIONED THAT SEVERAL NUMBERS OF PRODUCTS WERE AFFECTED. THE INCIDENT HAS BEEN REPORTED IN DIFFERENT HOSPITAL SERVICES DURING THE USE OF THE FOLEY CATHETERS IN USERS. IT WAS STATED THAT THERE HAD BEEN AN IMPACT ON USERS BECAUSE BEFORE IT WAS DETECTED THAT THE URINE DID NOT DRAIN PROPERLY INTO THE COLLECTION BAG IF IT WAS NOT PLACED ON THE FLOOR, VOLUME AND EVEN DIURETICS WERE ADMINISTERED TO USERS TO INCREASE THEIR URINARY OUTPUT. THERE HAD BEEN NO EXPOSURE OF BLOOD TO THE MUCOSA OR SKIN. THE EVENT OCCURRED ON SEVERAL PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, IT WAS STATED THAT BRA REFERS TO STATLOCK. AS PER FOLLOW UP INFORMAT

  Patient problems: Laceration(s)

  MAUDE report 15612857 ↗