Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741016950), received between Dec 28, 2018 and Nov 19, 2019 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2019Break; Component Missing

  IT WAS REPORTED THAT THE TIP OF THE FOLEY BROKE IN TWO PIECES INSIDE OF THE PATIENT. A CYSTOSCOPY WAS DONE AND THE TIP WAS NOT LOCATED INSIDE OF THE PATIENT, IT WAS UNKNOWN AS TO THE TIPS FINAL DESTINATION.

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 9341062 ↗
• MalfunctionDec 28, 2018Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NURSE IN THE TICU NOTICED A DARK MATERIAL IN THE HOLE AT THE TIP OF THE ANTI-INFECTIVE COUDE FOLEY CATHETER. SUBSEQUENTLY, THE REMAINING PRODUCT WAS PULLED FROM THE SHELVES PRIOR TO PATIENT USE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8204586 ↗