Bard® All Purpose Urethral Catheter 0094160Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00801741034039), received between May 9, 2017 and Sep 30, 2024 — classified as 1 injury, 87 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (25 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 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT 3 OF THE RED RUBBER LATEX INTERMITTENT CATHETERS THAT APPEARED TO BE DRY ROTTED OR USED AS THEY HAD WHITE LINES ON THEM. TWO OF THEM WERE 10FR WITH LOTS (LOT#NGHX2731 AND LOT#NGJT2540) AND ONE OF THEM WAS A 16FR WITH LOT (LOT#NGEU3771. CUSTOMER HAD SEVERAL OTHER SIZES OF THESE, SO THIS SEEMED TO BE ISOLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332590 ↗
• MalfunctionMay 25, 2022Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  IT WAS REPORTED THAT THE RED RUBBER INTERMITTENT CATHETER APPEARED TO BE BREAKING DOWN AROUND THE EYES. IT WAS STATED THAT SAFETY CONCERN WAS NOTICED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496600 ↗
• MalfunctionFeb 12, 2021Improper Chemical Reaction; Physical Resistance/Sticking; Improper Chemical Reaction; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE URETHRAL CATHETER WAS TACKY OR VERY STICKY ON THE INSERTION TIP, AND NOT SMOOTH. THE USER FOUND THE SAME ISSUE MORE OFTEN. PER FOLLOW UP INFORMATION RECEIVED ON 19JAN2021, THE USER DID NOT PUT LUBE ON THE CATHETER. IN OTHER CATHETER, THE USER FOUND WITH THE SAME ISSUE AND PUT LUBE ON IT, WHICH WAS STILL TACKY AND CAUSED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury

  MAUDE report 11321987 ↗
• MalfunctionFeb 10, 2021Improper Chemical Reaction; Physical Resistance/Sticking; Improper Chemical Reaction; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE URETHRAL CATHETER WAS TACKY OR VERY STICKY AT THE INSERTION TIP AND NOT SMOOTH. THE USER FOUND THE SAME ISSUE MORE OFTEN. PER FOLLOW UP INFORMATION RECEIVED ON 19JAN2021 THE USER DID NOT PUT THE LUBRICITY ON THE CATHETER. IN OTHER CATHETER THE USER FOUND WITH THE SAME ISSUE AND PUT LUBRICITY ON IT WHICH WAS STILL TACKY AND CAUSED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 11309423 ↗
• MalfunctionMay 11, 2020Sharp Edges; Scratched Material; Sharp Edges

  IT WAS REPORTED THAT THE CATHETERS WERE A BIT SHARP AND CAUSED A LITTLE PAIN WHEN USING.

  Patient problems: Pain

  MAUDE report 10043753 ↗
• MalfunctionMar 20, 2020Incorrect Measurement; Output above Specifications; Incorrect Measurement

  IT WAS REPORTED THAT THE DURING THE PRODUCT RETURN INVESTIGATION, THE CATHETERS HAD EYE LENGTHS ABOVE SPECIFICATIONS.

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

  MAUDE report 9859901 ↗
• MalfunctionMar 20, 2020Incorrect Measurement; Manufacturing, Packaging or Shipping Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE DURING THE PRODUCT RETURN INVESTIGATION THE CATHETERS HAD EYE LENGTHS ABOVE SPECIFICATIONS.

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

  MAUDE report 9859897 ↗
• MalfunctionMar 20, 2020Incorrect Measurement; Manufacturing, Packaging or Shipping Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE DURING THE PRODUCT RETURN INVESTIGATION, THE CATHETERS HAD EYE LENGTHS ABOVE SPECIFICATIONS.

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

  MAUDE report 9859893 ↗
• MalfunctionSep 10, 2019Misassembled; Positioning Problem; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYES ON THE CATHETER WERE PLACED TOO CLOSE TO THE TIP.

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

  MAUDE report 8983629 ↗
• MalfunctionSep 10, 2019Incorrect Measurement; Defective Component; Incorrect Measurement

  IT WAS REPORTED THAT THE DIAMETER OF THE TIP OF CATHETERS APPEARED LARGER THAN A 16 FR.

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

  MAUDE report 8983628 ↗
• MalfunctionSep 10, 2019Product Quality Problem; Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE SHAFT OF THE URETHRAL CATHETER HAD EXTRA MATERIAL WHICH CREATED A SHARP SPOT/BUMP.

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

  MAUDE report 8983322 ↗
• MalfunctionMar 15, 2019Misassembled; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYES OF THE URETHRAL CATHETER WERE NOT SYMMETRICAL.

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

  MAUDE report 8424179 ↗
• MalfunctionMar 15, 2019Misassembled; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYE OF THE URETHRAL CATHETER WAS NOT COMPLETELY PUNCHED OUT.

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

  MAUDE report 8424178 ↗
• MalfunctionMar 15, 2019Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE SHAFT OF THE URETHRAL CATHETER HAD EXTRA MATERIAL WHICH CREATED A SHARP SPOT/BUMP.

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

  MAUDE report 8424176 ↗
• MalfunctionMar 14, 2019Device Damaged Prior to Use; Sharp Edges; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE DRAINAGE EYES OF THE URETHRAL CATHETER WERE SHARP ON ONE SIDE.

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

  MAUDE report 8422529 ↗
• MalfunctionMar 14, 2019Deformation Due to Compressive Stress; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE URETHRAL CATHETER HAD A KNOT TIED IN IT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8422425 ↗
• MalfunctionFeb 28, 2019Misassembled; Material Puncture/Hole; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE HOLE ON THE CATHETER WAS MORE NEAR THE TIP AND THE TIP BENT EASILY WHEN GIVEN A LITTLE FORCE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 8377464 ↗
• MalfunctionFeb 28, 2019Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRAINAGE HOLE ON THE CATHETER WAS NEAR THE TIP AND THE TIP BENT EASILY WHEN GIVEN A LITTLE FORCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377342 ↗
• MalfunctionFeb 22, 2019Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETERS WERE SHARP AND BUMPY.

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

  MAUDE report 8361621 ↗
• MalfunctionFeb 21, 2019Misassembled; Product Quality Problem; Misassembled

  IT WAS REPORTED THAT PRIOR TO INSERTION, THE USER NOTICED THAT THE REMAINS OF THE PUNCTURED HOLES FOR THE DRAINAGE EYES ON THE CATHETER, WERE STILL ATTACHED AND HANGING ON THE DEVICE.

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

  MAUDE report 8359769 ↗
• MalfunctionFeb 21, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EDGE OF THE EYELETS CLOSEST TO THE TIP OF THE URETHRAL CATHETER WERE SHARP.

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

  MAUDE report 8359229 ↗
• MalfunctionFeb 21, 2019Misassembled; Manufacturing, Packaging or Shipping Problem; Misassembled

  IT WAS REPORTED THAT THE EYES ON THE URETHRAL CATHETER WERE TOO CLOSE TO THE TIP. THE COMPLAINANT NOTED THAT THERE WAS NOT ENOUGH SURFACE AREA BEFORE THE EYES ON THE CATHETER.

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

  MAUDE report 8359213 ↗
• MalfunctionFeb 21, 2019Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETERS HAD SHARP EYES. THE PATIENT SAVED THE CATHETERS, BUT DID NOT USE THEM.

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

  MAUDE report 8359194 ↗
• MalfunctionDec 27, 2018Misassembled; Misassembled; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE EYELET ON THE CATHETER WAS CUT CLOSER ON ONE SIDE THAN ON THE OTHER SIDE.

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

  MAUDE report 8201439 ↗
• MalfunctionDec 27, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Material Integrity Problem

  IT WAS REPORTED THAT THE EYELETS ON THE CATHETER WERE TOO SHARP. THE COMPLAINANT REPORTED THAT THE PORTION OF THE EYELETS CLOSEST TO THE TIP WAS NOTED TO BE THE SHARPEST.

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

  MAUDE report 8200881 ↗