Bardia® Foley Catheter Insertion Tray 802130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741018275), received between May 14, 2018 and Jul 13, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SYRINGE TO FILL BALLOON WAS BROKEN WHEN THEY TRIED TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000007 ↗
• MalfunctionDec 15, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ONE OF THE INSERTION TRAYS WERE OPENED ON THE LAST ORDER SO THE PATIENT THROWN THE TRAY AWAY AND DID NOT USE IT DUE TO THE RISK OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11012932 ↗
• InjuryMay 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL PRESENT ON THE GLOVES WITHIN THE FOLEY TRAY; THEREFORE, THE COMPLAINANT USED THE KIT WITHOUT THE GLOVE. IT WAS REPORTED THAT, AS A RESULT, THE PATIENT ALLEGEDLY EXPERIENCED A UTI, FOR WHICH ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Urinary Tract Infection

  MAUDE report 7510927 ↗