Bard® Foley Tray with Bard® Hydrophilic-Coated Foley Catheter 800361Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741040313), received between Jan 31, 2019 and Jan 31, 2019 — classified as 1 malfunction.

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

• MalfunctionJan 31, 2019Break; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE LUBRICANT SYRINGE IN THE LUBRICATH FOLEY TRAY WAS BROKEN. THE LUBRICANT WITHIN THE SYRINGE DRIED AND TURNED YELLOW. THERE WERE NO REPORTS OF LEAKAGE WITHIN THE TRAY.

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

  MAUDE report 8294034 ↗