Bard® All Purpose Urethral Catheter 0094120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741034015), received between Sep 16, 2020 and Feb 19, 2025 — classified as 2 malfunctions.

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.

• MalfunctionFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN #277710(BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390, (BATCH #NGGQ3730], [PCN #277708 (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682], [PCN #94100 (BATCH #NGEY3152], ]PCN #94120(BATCH #NGEV4510], [PCN #56110(BATCH #NGFW2958], [PCN #56114(BATCH #NGGV2774]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 05MAR2025, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409856 ↗
• MalfunctionSep 16, 2020Break; Contamination /Decontamination Problem; Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CATHETERS HAD AN ALLEGED WHITE POWDER, FILM OR RESIDUE ON THEM AND WERE NOT USED. AS PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25AUG2020 FROM THE INVESTIGATOR, THE CATHETER WAS FOUND TO HAVE OZONE DAMAGE DURING THE EVALUATION.

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

  MAUDE report 10541630 ↗