Bard Clean-Cath CatheterRecalls & reported problems across all models

We found 2 models of Bard Clean-Cath Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Nov 13, 2020 — classified as 8 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Misassembled” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bard Clean-Cath Catheter problems

Bard Clean-Cath Catheter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® Clean-Cath® Catheter 421614

  CATHETER, UROLOGICAL
  46 reports
• Bard® Clean-Cath® Catheter 420614

  CATHETER, UROLOGICAL
  7 reports

Recent Bard Clean-Cath Catheter adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 28, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT PATIENT WAS TREATED FOR A URINARY TRACT INFECTION A COUPLE OF WEEKS AGO, AND ALTHOUGH THERE WAS NO ALLEGATION AGAINST ANY PRODUCT, PATIENT WAS HISTORICALLY PROVIDED WITH THE 420614. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO URINARY TRACT INFECTION AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10468705 ↗
• InjuryAug 12, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT PATIENT GOT URINARY TRACT INFECTION AND ALTHOUGH THERE WAS NO ALLEGATION AGAINST ANY PRODUCT. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10396499 ↗
• 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 ↗
• MalfunctionMar 17, 2020Component Missing

  IT WAS REPORTED THAT ONE OF THE KITS WAS MISSING THE CATHETERS AND ANOTHER KIT HAD A CATHETER WITH NO EYELETS.

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

  MAUDE report 9841625 ↗
• MalfunctionMar 17, 2020Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT ONE OF THE KITS WAS MISSING THE CATHETER AND ANOTHER KIT HAD A CATHETER WITH NO EYELETS.

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

  MAUDE report 9841600 ↗
• 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 ↗

Other C. R. Bard, Inc. products

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• Bardex All-Silicone Foley Catheter12 models · 1,170 reports