Bard® Urethral Catheterization Tray with Red Rubber Catheter 771215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741030499), received between Sep 6, 2018 and Jul 14, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2020Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE WAS NO URINE GOT BACK INTO THE BAG, WHEN THE CATHETER WAS FULLY INSERTED. MSS ADVISED THE USER TO MAKE SURE THAT THE CLAMP WAS RELEASED.

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

  MAUDE report 10271092 ↗
• MalfunctionApr 17, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT NO URINE DRAINED FOLLOWING INSERTION OF THE CATHETER. THE STAFF REMOVED THE UNKNOWN RED RUBBER FOLEY AND ATTEMPTED TO FLUSH IT AND FOUND THAT IT WAS OBSTRUCTED AND COULD NOT FLOW. A CATHETER WAS INSERTED AND URINE DRAINAGE WAS SUCCESSFUL.

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

  MAUDE report 8522974 ↗
• MalfunctionSep 6, 2018Component Missing

  IT WAS REPORTED THAT THE LUBRICANT PACKAGE WAS MISSING FROM THE FOLEY TRAY.

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

  MAUDE report 7850780 ↗