Bard® Foley Tray with Hydrophilic-Coated Foley Catheter 861014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741040382), received between Apr 23, 2021 and Apr 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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.

• MalfunctionApr 23, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INFLATE THE FOLEY CATHETER, THE CAP OF THE SYRINGE WAS MISSING AND THE SYRINGE WAS DRY. THE STERILE OUTER PACKAGE WAS COMPLETELY INTACT WITH NO EVIDENCE THAT IT HAD EVER BEEN OPENED. IT WAS ALSO REPORTED THAT THERE WAS NO CAP ON THE LUER TIP. THE CATHETER COULD NOT BE USED AND WAS DISCARDED. PER FOLLOW UP VIA MAIL ON (B)(6) 2021, CUSTOMER HAD ONE KIT DEFECT AND HAD TWO OTHERS UNOPENED YET. THE CAP ON THE LUER TIP WAS MISSING AND SYRINGE WAS DRY INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715897 ↗