Bard® Clean-Cath® Intermittent Catheter 421714Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741038822), received between Sep 26, 2017 and May 5, 2023 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN ON REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875943 ↗
• MalfunctionFeb 6, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE VINYL CATHETER MADE THE PATIENT TO BLEED IN THE PAST. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA PHONE ON (B)(6) 2022, IT WAS STATED THAT THE VINYL CATHETER WAS A SUBSTITUTE BECAUSE THE CUSTOMER'S NORMAL CATHETERS WERE ON BACKORDER. THEY DESCRIBED THE CATHETER AS EXTREMELY SLIPPERY AND THEY HAD ISSUES WITH THE GRIPPER. THEY DESCRIBED THESE AS DIFFICULT FOR THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467512 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE VINYL CATHETER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305040 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN AND CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304353 ↗
• MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS BROKE AND CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300302 ↗
• MalfunctionMay 18, 2021Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER HAD A TEAR OR RIP AT THE INSERTION END. THE CUSTOMER COMPLAINED THAT THE CATHETER TORE THE PATIENT'S URETHRA AND THE PATIENT HAD TO GO TO THE EMERGENCY DEPARTMENT. THE PROBLEM WAS IDENTIFIED DUE TO THE AMOUNT OF BLOOD LOSS PRIOR GOING TO THE EMERGENCY DEPARTMENT. THE PATIENT HAD EXCESSIVE BLEEDING. THE PATIENT WAS ON BLOOD THINNERS AND THEY BELIEVED THAT IT WAS HEALED.

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

  MAUDE report 11842012 ↗
• InjuryMar 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CATHETERS HAD A GROSS WHITE SUBSTANCE ON THEM PERHAPS FROM THE PACKAGE. IT WAS STATED THE PATIENT HAD A URINARY TRACT INFECTION WENT TO THE UROLOGIST AND WOULD BE GETTING ANTIBIOTICS LATER. THE USER FURTHER REPORTED THAT APPROXIMATELY 7 CATHETERS WERE BAD. THE USER THOUGHT THAT WHILE CATHETERIZING THE PATIENT DURING THE NIGHT THEY DID NOT NOTICE AND CATHETERIZED THE PATIENT.

  Patient problems: Urinary Tract Infection

  MAUDE report 11580343 ↗
• MalfunctionMar 26, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE 3-4 OF THE CLEAN VINYL CATHETERS CAME WITH A SLIGHTLY BENT TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574755 ↗
• MalfunctionFeb 23, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO GREEN FUNNEL ON ALL CATHETERS.

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

  MAUDE report 11365627 ↗
• InjuryDec 28, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A BREAK IN THE CATHETER. IT WAS ALSO ALLEGED THAT THERE WAS AN UNEXPECTED MEDICAL INTERVENTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11076777 ↗
• MalfunctionDec 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A BREAK/CRACK IN THE CATHETER.

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

  MAUDE report 11064848 ↗
• MalfunctionJun 25, 2020Difficult to Insert

  IT WAS REPORTED THAT PATIENT HAD STRICTURE AND CATHETER COULD NOT BE INSERTED. PATIENT ALSO STATED THAT THE 14F MAY BE TOO BIG.

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

  MAUDE report 10194620 ↗
• MalfunctionJun 5, 2020Partial Blockage; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETERS WERE CLOGGED AND THE CAUSE WAS UNKNOWN.

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

  MAUDE report 10122738 ↗
• InjuryApr 21, 2020Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A CRACK ON THE CATHETER. THE TIP OF THE CATHETER BROKE INSIDE OF THE PATIENT (WHILE STILL CONNECTED) DURING INSERTION, LEAVING A SHARP EDGE WHICH ALLEGEDLY CUT THE PATIENT. REPORTEDLY, THE CATHETER CAME OUT IN ONE PIECE AND MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Patient Problem/Medical Problem; Tissue Damage

  MAUDE report 9981934 ↗
• MalfunctionMar 24, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETER CLOGGED.

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

  MAUDE report 9873404 ↗
• MalfunctionMar 21, 2020Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE PATIENT WAS PULLING THE CATHETER OUT, IT FELT LIKE IT SNAGGED OR WAS A LITTLE ROUGH COMING OUT.

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

  MAUDE report 9863570 ↗
• InjuryDec 27, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FEW CATHETERS THAT WERE BENT. THE CUSTOMER NOTED THAT HE STRAIGHTENED ONE OF THE CATHETERS AND USED IT. ALLEGEDLY, WHILE THE CATHETER WAS IN SITU, IT HAD BENT AGAIN AND PIERCED THROUGH THE ¿LINER¿ WHICH CAUSED SOME BLEEDING. THE CUSTOMER REPORTED THAT HE ENDED UP HAVING SURGERY AND A PERMANENT CATHETER PLACED DUE TO THE REPORTED EVENT. THE CUSTOMER DID NOT SAVE ANY OF THE DEFECTIVE PRODUCTS. 19DEC2019- UPDATE: DR. (B)(6) IS THE CORRECT UROLOGIST/SPECIALIST - HE DID THE SCOPE ON (B)(6) TO FOLLOW UP WITH REMOVING THE PERMANENT CATHETER AND RETURN TO SELF CATHING AT (B)(6) HOSPITAL. PERMANENT CATH HAD BEEN INSERTED IN NEW GLASGOW BY THE ER ATTENDING. STILL FINDS OCCASIONAL SLIGHT BEND BUT THEY ARE USABLE AS THEY DO/CAN BE STRAIGHTENED OUT.

  Patient problems: Blood Loss; Injury; Patient Problem/Medical Problem

  MAUDE report 9526571 ↗
• MalfunctionAug 8, 2019Nonstandard Device; Defective Component; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETERS WERE NOT WORKING PROPERLY.

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

  MAUDE report 8876018 ↗
• MalfunctionJun 12, 2019Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS WERE DIFFICULT TO INSERT AND CAUSED THE PAIN DURING INSERTION OF THE DEVICE. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 8692122 ↗
• MalfunctionMay 28, 2019Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT THE VINYL CATHETERS WERE "JAMMED INTO" THE BOXES, CAUSING THEM TO BE BENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8645612 ↗
• MalfunctionFeb 11, 2019Difficult to Insert; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SELF LIMITED BLEEDING AND WAS UNABLE TO FULLY INSERT THE CATHETERS. THE PATIENT VISITED THE EMERGENCY ROOM WHERE A DOCTOR ATTEMPTED TO INSERT A CATHETER BUT WAS UNSUCCESSFUL. THE DOCTOR EXPLAINED TO THE PATIENT THAT THERE WAS "BLOCKAGE" AND HE COULD NOT USE THE CATHETERS AT THAT TIME. THE PATIENT WAS NOT ALLEGING THE CATHETERS WERE THE REASON FOR THE BLOCKAGE, AND NOTED THAT HE WOULD FOLLOW UP WITH THE UROLOGIST AS SUGGESTED BY ER PHYSICIAN. THE PHYSICIAN ALSO NOTED THAT HE MAY HAVE UNDERLYING MEDICAL ISSUES THAT CAUSED THE BLOCKAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8329159 ↗
• InjuryFeb 6, 2019Misassembled; Material Deformation; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE DEFORMED CAUSING THE EYELETS TO SCRATCH THE PATIENT AND CAUSE A SMALL AMOUNT OF BLEEDING. THE PATIENT ALSO NOTED THAT HE CONTRACTED A UTI AND WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 8312288 ↗
• InjuryAug 31, 2018Break; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CATHETER BROKE 5-6 INCHES FROM THE TIP INSIDE THE PATIENT'S URETHRA. AN X-RAY WAS TAKEN BUT THE IMAGING WAS UNABLE TO DISPLAY IF THE BROKEN PIECE WAS STILL IN THE PATIENT. THE PATIENT ALLEGEDLY EXPERIENCED BLOOD IN HIS URINE AS A RESULT. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON (B)(6) 2018, IT WAS ALLEGED THAT THE CATHETER HAD BEEN CHEWED IN HALF BY THE PATIENT PRIOR TO INSERTION INTO HIS URETHRA. THE PATIENT WAS TAKEN TO (B)(6), WHERE THE PATIENT WAS ADMITTED. THE COMPLAINANT STATED THAT THEY BELIEVE THE BREAK WAS DONE BY THE PATIENT PURPOSEFULLY SO THAT HE COULD BE ESCORTED FROM THE PENITENTIARY TO SPEND TIME IN THE HOSPITAL WHERE THERE IS AIR CONDITIONING AND A COMFORTABLE BED.

  Patient problems: Foreign Body In Patient; Hematuria; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7838786 ↗
• InjuryAug 31, 2018Break; Entrapment of Device; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CATHETER BROKE 5-6 INCHES FROM THE TIP INSIDE THE PATIENT'S URETHRA. ALLEGEDLY, A SURGICAL PROCEDURE WAS REQUIRED TO THE REMOVE THE BROKEN PIECE OF THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON (B)(6) 2018, THE PATIENT ALLEGEDLY USED FINGERNAIL CLIPPERS TO INTENTIONALLY BREAK THE CATHETER PRIOR TO INSERTION IN HIS URETHRA. THE COMPLAINANT STATED THAT THEY BELIEVE THE BREAK WAS DONE BY THE PATIENT PURPOSEFULLY SO THAT HE COULD BE ESCORTED FROM THE PENITENTIARY TO SPEND TIME IN THE HOSPITAL WHERE THERE IS AIR CONDITIONING AND A COMFORTABLE BED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7838593 ↗
• MalfunctionAug 15, 2018Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER HAD A KINK IN IT WITHIN THE PACKAGING. THE PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT DURING USE OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 7786025 ↗