Bard® Safety-Flow™ Foley Catheter Tray with Hydrophilic-Coated Foley Catheter 907716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741024184), received between Nov 13, 2017 and Jun 20, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT THE NURSE HAD A LATEX REACTION WHILE HANDLING THE CONTENTS OF THE TRAY. THE NURSE REPORTEDLY WENT TO URGENT CARE AND WAS RELEASED THE SAME DAY. PER ADDITIONAL INFORMATION RECEIVED FROM THE DIRECTOR AT THE COMPLAINANT'S FACILITY VIA PHONE ON 11 JUN 2019, THE NURSE WAS EXPERIENCING AN ITCHING SENSATION ON THE HAND WHICH RESULTED IN SCRATCHED. THE NURSE ALSO REPORTEDLY HAD A TINGLING SENSATION ON THE LIPS. THE NURSE REPORTEDLY RECEIVED BENADRYL AND SOLU-MEDROL INJECTIONS ALONG WITH A PREDNISONE PRESCRIPTION.

  Patient problems: Itching Sensation; Laceration(s); Reaction; Tingling

  MAUDE report 8716831 ↗
• MalfunctionNov 13, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7024841 ↗