Bard® Clean-Cath® Intermittent Catheter 421712Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741038815), received between Sep 5, 2017 and May 14, 2022 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2022Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VINYL CATHETER HAD AN UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PER FOLLOW-UP INFORMATION RECEIVED FROM (B)(6) TEAM ON 20APR2022, STATED THAT THE PATIENT EXPERIENCED DISTRESS, ABDOMINAL PAIN. IT WAS ALSO STATED THAT THEY REQUIRED HOSPITALIZATION OR PROLONGED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTION. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body In Patient; Pain

  MAUDE report 14402888 ↗
• MalfunctionAug 10, 2021Disconnection; Decrease in Pressure; Disconnection; Decrease in Pressure

  IT WAS REPORTED THAT THE VINYL CATHETER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305233 ↗
• InjuryApr 8, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION WITH BAR421712 (VINYL CATHETER) AND REQUESTED TO SEND MTG32112, BECAUSE THEY ARE MORE STERILE THAN THE KITS THE PATIENT WAS GETTING IN PREVIOUS ORDER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11636550 ↗
• InjuryApr 2, 2020Deflation Problem; Material Fragmentation; Detachment of Device or Device Component; Deflation Problem

  IT WAS REPORTED THAT UPON REMOVAL OF THE CATHETER, THE WHITE TIP CAME OUT ONLY LEAVING THE REMAINDER OF THE CATHETER INDWELLED. THE PATIENT WENT TO THE HOSPITAL (B)(4) HOURS AWAY TO HAVE THE CATHETER FULLY REMOVED. REPORTEDLY, THE CATHETER WAS REMOVED SURGICALLY BY A UROLOGIST. THE PATIENT WAS AT HOME, BUT ALLEGED BLADDER SPASMS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2020 FROM IBC REPRESENTATIVE, A CYSTOSCOPY WAS PERFORMED ON THE PATIENT TO REMOVE THE CATHETER. THE CATHETER WAS IN TWO PIECES, AND IT WAS REMOVED BY A PHYSICIAN. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT THAT SAME NIGHT, AND WAS PRESCRIBED CIPROFLOXACIN 500MG. THE PATIENT WAS ALSO PRESCRIBED MORPHINE FOR PAIN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Muscle Spasm(s); Pain; Patient Problem/Medical Problem

  MAUDE report 9915392 ↗
• MalfunctionNov 7, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT/MISSHAPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9293735 ↗
• MalfunctionOct 17, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS BENT IN THE PACKAGING PRIOR TO USE. ALLEGEDLY THE PATIENT DID NOT TRY AND INSERT THE CATHETER.

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

  MAUDE report 7973260 ↗
• MalfunctionOct 16, 2018Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS BENT IN THE PACKAGING PRIOR TO USE. ALLEGEDLY THE PATIENT DID NOT TRY AND INSERT THE CATHETER.

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

  MAUDE report 7971509 ↗
• MalfunctionOct 16, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS BENT IN THE PACKAGING PRIOR TO USE. ALLEGEDLY THE PATIENT DID NOT TRY AND INSERT THE CATHETER.

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

  MAUDE report 7971489 ↗
• InjurySep 5, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION WHILE USING THE CATHETER. THE PATIENT REPORTED THAT THE CATHETERS WERE RE-STERILIZED.

  Patient problems: Urinary Tract Infection

  MAUDE report 6841836 ↗
• InjurySep 5, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION WHILE USING THE CATHETER. THE PATIENT REPORTED THAT THE CATHETERS WERE RE-STERILIZED.

  Patient problems: Urinary Tract Infection

  MAUDE report 6841788 ↗