Bard® All Purpose Urethral Catheter 0094080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741033995), received between Dec 21, 2018 and Dec 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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.

• MalfunctionDec 3, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS DEFECTIVE UPON ARRIVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12928884 ↗
• MalfunctionDec 21, 2018Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A QUALITY ISSUE WITH THE PRODUCT. THE PRODUCT WAS NOT USED ON A PATIENT. IT WAS LATER REPORTED, THAT THE PRODUCT (LATEX CATHETER) PACKAGING WAS BEING RECEIVED OPEN. NO MEDICAL INTERVENTION WAS REQUESTED.

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

  MAUDE report 8189704 ↗