Bard® All Purpose Urethral Catheter 0094140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741034022), received between Mar 4, 2019 and Sep 9, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE RED RUBBER INTERMITTENT CATHETER WAS FLIMSY AND THE PATIENT FELT THAT IT WAS MADE DIFFERENTLY. PER FOLLOW UP VIA PHONE ON (B)(6) 2021 THE CUSTOMER NOTICED A CHANGE IN THE CATHETERS THEY USED FOR YEARS. THE CATHETERS WERE FLIMSY WHICH MAKES THEM DIFFICULT TO USE. THEY FEEL LIKE THE DIAMETER WAS SMALLER THAN THE INDICATED 14 FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448826 ↗
• MalfunctionDec 15, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT CATHETERS WERE TOO THICK AND UNCOMFORTABLE.

  Patient problems: Discomfort

  MAUDE report 11006496 ↗
• MalfunctionOct 23, 2020Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CATHETER WAS FOUND DIFFICULT TO INSERT INSIDE THE BLADDER WHICH CAUSED THE SPHINCTER TO SPASM; ALSO THE PATIENT EXPERIENCED INCOMPLETE BLADDER URINATION DUE TO THE USE OF CATHETER. THE COMPLAINANT REPORTEDLY STATED THAT THE NEWER BARD CATHETERS MEASURED ABOUT 0.020 OF AN INCH LARGER IN DIAMETER WHEN COMPARED WITH OLDER BARD 9414 CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10730103 ↗
• MalfunctionOct 23, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS FOUND DIFFICULT TO INSERT INSIDE THE BLADDER WHICH CAUSED THE SPHINCTER TO SPASM; ALSO THE PATIENT EXPERIENCED INCOMPLETE BLADDER URINATION DUE TO THE USE OF CATHETER. THE COMPLAINANT REPORTEDLY STATED THAT THE NEWER BARD CATHETERS MEASURED ABOUT 0.020 OF AN INCH LARGER IN DIAMETER WHEN COMPARED WITH OLDER BARD 9414 CATHETERS.

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

  MAUDE report 10729683 ↗
• InjuryAug 28, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS RECENTLY TREATED FOR URINARY TRACT INFECTION. HISTORICALLY PATIENT WAS PROVIDED WITH THE URETHRAL CATHETER BAR0094140. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO URINARY TRACT INFECTION .

  Patient problems: Urinary Tract Infection

  MAUDE report 10464923 ↗
• MalfunctionAug 17, 2020Defective Device; Material Twisted/Bent; Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CATHETERS FROM THE LAST TWO BATCHES WERE NOT STIFF ENOUGH. THE HOLES ON THE TIP WERE ON OPPOSITE SIDES, WHICH CAUSED THE CATHETER TO BEND OVER WHEN TRYING TO INSERT.

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

  MAUDE report 10417404 ↗
• MalfunctionJul 31, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE HAD WHITE PARTICLES INSIDE THE COMPONENT.

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

  MAUDE report 10353307 ↗
• MalfunctionJul 30, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE HAD WHITE PARTICLES INSIDE THE COMPONENT.

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

  MAUDE report 10346728 ↗
• MalfunctionMar 4, 2019Misassembled; No Flow; Misassembled

  IT WAS REPORTED THAT THE EYELETS ON THE URETHRAL CATHETER WERE "CLOSED", WHICH PREVENTED THE URINE FROM DRAINING THROUGH.

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

  MAUDE report 8388657 ↗