Bard® Clean-Cath® Catheter 420614Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741038921), received between Jun 12, 2018 and Aug 28, 2020 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJan 29, 2019Difficult to Insert; Material Deformation; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CLEAN VINYL CATHETER WAS WARPED/CURVED INSIDE OF THE PACKAGING MAKING IT DIFFICULT, AND UNCOMFORTABLE FOR THE PATIENT TO INSERT. NO PATIENT INJURY REPORTED.

  Patient problems: Discomfort

  MAUDE report 8284889 ↗
• MalfunctionJan 9, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE FEMALE VINYL CATHETER WAS BENT. THE CATHETER WAS INSERTED BUT THE PATIENT WAS UNABLE TO VOID USING THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; Urinary Retention

  MAUDE report 8231580 ↗
• MalfunctionJun 12, 2018Misassembled; Malposition of Device; Misassembled

  IT WAS REPORTED THAT THE CATHETER WAS PLACED BACKWARDS INSIDE OF THE PACKAGING.

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

  MAUDE report 7591884 ↗