Bard® Clean-Cath® Catheter 421614Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00801741038976), received between Apr 20, 2017 and Nov 13, 2020 — classified as 6 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Misassembled” (32 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT NOTICED AFTER FOUR MONTHS OF BUYING THE CLEAN CATH VINYL CATHETER THE PLASTIC WAS ALLEGEDLY NOT SMOOTH AND INSTEAD IT WAS STICKY. PER EVALUATION, THE PATIENT HAS USED EXPIRED PRODUCT OFTEN.

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

  MAUDE report 10837171 ↗
• MalfunctionOct 28, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE THERE WERE NO DRAINAGE EYES IN THE CATHETER. ALSO STATED THAT IT WAS NOT THE FIRST TIME THIS HAPPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10752033 ↗
• MalfunctionApr 9, 2020Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PATIENT SAID IN THE ORDER THERE WERE ABOUT 15 CATHETERS THAT THE PACKING WAS OPEN. HE STATED HE THREW THEM AWAY.

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

  MAUDE report 9945248 ↗
• MalfunctionDec 12, 2019Product Quality Problem; Product Quality Problem; Packaging Problem

  IT WAS REPORTED THAT THE PATIENT¿S WIFE STATED THE PATIENT HAD BEEN DEALING WITH THE CATHETERS STICKING TO PACKAGE.

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

  MAUDE report 9461278 ↗
• InjuryNov 22, 2019Misassembled; Misassembled; Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE CATHETER UPSIDE DOWN IN THE SLEEVE/PACKAGE. THE CUSTOMER STATED HE HAD A UTI FROM USING THE PRODUCT. THE CUSTOMER ALSO STATED THE PACKAGING SEEN ON THE SUPPLIER WEBSITE DISPLAYED THE TIP FACING IN THE CORRECT DIRECTION. PER FOLLOW UP PHONE CALL WITH CUSTOMER ON (B)(6) 2019, THEY RECEIVED BACTRIM DS MEDICATION TO TREAT THE UTI. THE CUSTOMER WAS TO SEND THE UNUSED SAMPLE BACK.

  Patient problems: Patient Problem/Medical Problem; Urinary Tract Infection

  MAUDE report 9364740 ↗
• MalfunctionNov 22, 2019Misassembled; Misassembled; Packaging Problem

  IT WAS REPORTED THAT THE CATHETER WAS PACKAGED BACKWARDS, SO THE PATIENT HAD TO TOUCH THE CATHETER IN ORDER TO GET IT OUT OF THE PACKAGE AND INSERTED.

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

  MAUDE report 9362163 ↗
• MalfunctionNov 6, 2019Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE CUSTOMER DOES NOT LIKE THE WAY THE CATHETER IS PACKAGED. IT WAS LATER REPORTED ON 19OCT2019,THE CUSTOMER STATED HE PREFERRED WHEN THE ROUND TIP WAS EXPOSED FOR INSERTION, RATHER THAN THE CURRENT PACKAGING WHERE THE CATHETER HAS TO BE COMPLETELY REMOVED FROM THE PACKAGE TO INSERT.

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

  MAUDE report 9284590 ↗
• InjurySep 26, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CUSTOMER ALLEGEDLY EXPERIENCED FREQUENT UTIS WITH USE OF THIS CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 9122853 ↗
• InjuryMay 20, 2019Misassembled; Difficult to Insert; Misassembled; Packaging Problem

  IT WAS REPORTED THAT THE CATHETERS WERE PACKAGED UPSIDE DOWN IN THE PACKAGING WHICH ALLEGEDLY PREVENTS THE PATIENT FROM INSERTING THE CATHETER WITHOUT IT BEING TOUCHED. THE PATIENT REPORTEDLY DEVELOPED A URINARY TRACT INFECTION. THE PATIENT WAS NOT PRESCRIBED ANY MEDICATION REPORTEDLY DUE TO A CONCERN OF BECOMING IMMUNE TO THE MEDICATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 8624828 ↗
• MalfunctionMay 1, 2019Misassembled; Positioning Problem; Misassembled

  IT WAS REPORTED THAT THE VINYL CATHETER WAS PACKAGED BACKWARDS. THE PATIENT NOTICED THIS ISSUE PRIOR TO INSERTING THE CATHETER AND VOIDING.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8570595 ↗
• InjuryMay 1, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A UTI AFTER USE OF THE VINYL CATHETER. THE PATIENT WAS TREATED WITH BACTRIM.

  Patient problems: Urinary Tract Infection

  MAUDE report 8570590 ↗
• MalfunctionApr 9, 2019Misassembled; Device Misassembled During Manufacturing /Shipping; Misassembled

  IT WAS REPORTED THAT THE TOUCHLESS PLUS VINYL CATHETER WAS PACKAGED UPSIDE DOWN.

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

  MAUDE report 8497743 ↗
• MalfunctionApr 9, 2019Misassembled; Manufacturing, Packaging or Shipping Problem; Misassembled

  IT WAS REPORTED THAT THE TOUCHLESS PLUS VINYL CATHETER WAS PACKAGED UPSIDE DOWN.

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

  MAUDE report 8497742 ↗
• MalfunctionApr 9, 2019Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE TOUCHLESS PLUS VINYL CATHETER WAS PACKAGED UPSIDE DOWN.

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

  MAUDE report 8497738 ↗
• MalfunctionApr 9, 2019Misassembled; Device Misassembled During Manufacturing /Shipping; Misassembled

  IT WAS REPORTED THAT THE TOUCHLESS PLUS VINYL CATHETER WAS PACKAGED UPSIDE DOWN.

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

  MAUDE report 8497737 ↗
• MalfunctionApr 9, 2019Misassembled; Malposition of Device; Misassembled

  IT WAS REPORTED THAT THE TOUCHLESS PLUS VINYL CATHETER WAS PACKAGED UPSIDE DOWN.

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

  MAUDE report 8497731 ↗
• MalfunctionMar 29, 2019Misassembled

  IT WAS REPORTED THAT THE CLEAN CATH VINYL CATHETER WAS PACKAGED BACKWARDS.

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

  MAUDE report 8466954 ↗
• MalfunctionMar 19, 2019Misassembled; Device Misassembled During Manufacturing /Shipping; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE ASSEMBLED BACKWARDS IN THE PACKAGING AND CAUSED THE USER TO HAVE TO TOUCH THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8434456 ↗
• MalfunctionMar 19, 2019Misassembled; Device Misassembled During Manufacturing /Shipping; Misassembled

  IT WAS REPORTED THAT THE PRODUCTS WERE IN THE PACKAGING BACKWARDS. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8434002 ↗
• InjuryMar 19, 2019Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE PACKAGED UPSIDE DOWN, WHICH ALLEGEDLY PREVENTED THE PATIENT FROM INSERTING THE CATHETER WITHOUT IT BEING TOUCHED. THE PATIENT REPORTEDLY DEVELOPED A UTI AS RESULT OF USING THE CATHETERS AND WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 8433021 ↗
• MalfunctionMar 18, 2019Misassembled; Device Misassembled During Manufacturing /Shipping; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE ASSEMBLED BACKWARDS IN THE PACKAGING CAUSING THE USER TO HAVE TO TOUCH THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8429666 ↗
• MalfunctionMar 14, 2019Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE CLEAN CATH VINYL CATHETER WAS PACKAGED BACKWARDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422474 ↗
• InjuryFeb 14, 2019Misassembled; Patient-Device Incompatibility; Packaging Problem; Misassembled; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PRODUCT WAS PACKAGED INCORRECTLY AND ALLEGEDLY CAUSED THE PATIENT A URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 8339559 ↗
• MalfunctionFeb 6, 2019Misassembled; Manufacturing, Packaging or Shipping Problem; Misassembled

  IT WAS REPORTED THAT THE VINYL CLEAN CATHETER WAS PACKAGED BACKWARDS INSIDE OF THE PACKAGING.

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

  MAUDE report 8312292 ↗
• MalfunctionJan 30, 2019Misassembled; Packaging Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE LOADED INTO THE PACKAGING BACKWARDS. THE PATIENT ADVISED THAT WHEN HE OPENED THE PACKAGE HE HAD TO TOUCH THE ENTIRE CATHETER TO GET THE INSERTION SIDE. THE PATIENT REPORTED THAT HE DID NOT USE THE PRODUCT DUE TO THE FEAR OF INFECTION.

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

  MAUDE report 8290157 ↗