Bardia Urethral Catheter Tray 802100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741051180), received between May 8, 2020 and Oct 21, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE SYRINGE WAS MISSING FROM THE INSERTION TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 10713542 ↗
• MalfunctionSep 4, 2020Component Missing

  IT WAS REPORTED THAT NONE OF THE INSERTION TRAYS HAD WATER INSIDE THE SYRINGES TO BLOW UP THE BALLOON IN ORDER TO ANCHOR THE FOLEY CATHETER IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10493804 ↗
• MalfunctionJul 30, 2020Problem with Sterilization; Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WERE NO SYRINGES IN THE INSERTION TRAYS AND THE GLOVES UNDERNEATH EVERYTHING MAKES IT NEARLY IMPOSSIBLE TO STAY STERILE. ALSO STATED THAT THE MANUFACTURING WAS NOT GOOD AND IT WILL FOR SURE GIVE A PATIENT AN INFECTION.

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

  MAUDE report 10346622 ↗
• MalfunctionMay 8, 2020Component Missing

  IT WAS REPORTED THAT GLOVES AND SYRINGES WERE MISSING FROM THE URETHRAL INSERTION TRAYS.

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

  MAUDE report 10038220 ↗