Bardex® I.C. Short Tip Foley Catheter 0119SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741017247), received between Feb 20, 2020 and Feb 20, 2020 — 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.

• MalfunctionFeb 20, 2020Break; Fluid/Blood Leak; Break

  IT WAS REPORTED THAT THE URINE LEAKED FROM ONE OF THE LUMENS AT THE TOP OF THE 3 WAY FOLEY CATHETER. THE PATIENT WAS REPORTEDLY USING A 2 WAY CATHETER IN THE PAST, BUT WAS SENT THIS ONE AND THEN STARTED EXPERIENCING LEAKAGE. PER CONSULT WITH MSS, THE 3 WAY CATHETER SHOULD BE FOR HOSPITAL USE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9733255 ↗