Bard® Clean-Cath® Intermittent Catheter 420714Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741038747), received between Nov 7, 2018 and Dec 7, 2020 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2020Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT RAN OUT OF SUPPLIES AND REUSED THE SAME CATHETER MULTIPLE TIMES WHICH RESULTED IN A URINARY TRACT INFECTION. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10960674 ↗
• InjuryOct 12, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION AND FELT THAT IT MIGHT BE BECAUSE OF THE CATHETERS. ALSO, STATED THE PATIENT HAD ISSUES WITH THE INSERTION. PER FOLLOW UP, THE CUSTOMER NOTED THAT THE INFECTION WAS TREATED WITH PRESCRIBED ANTIBIOTICS AND THE CATHETERS WERE DIFFICULT TO INSERT, BUT THE PATIENT WAS STILL ABLE TO USE THEM.

  Patient problems: Unspecified Infection

  MAUDE report 10667195 ↗
• MalfunctionSep 2, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE 50 CLEAN CATH CATHETERS WERE BENT OR DEFECTIVE.

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

  MAUDE report 10483462 ↗
• MalfunctionJan 3, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT LIKE A CIRCLE/MOON SHAPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9547137 ↗
• InjuryJul 18, 2019Difficult to Insert

  IT WAS REPORTED THAT THE VINYL CATHETER WAS DIFFICULT TO INSERT. THE PATIENT DEVELOPED A URINARY TRACT INFECTION; TREATMENT PROVIDED IS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 8802371 ↗
• MalfunctionDec 27, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Scratched Material

  IT WAS REPORTED THAT THE SURFACE OF THE VINYL CATHETER FELT ROUGH AND SEEMED TO SCRATCH UPON INSERTION. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND DISCOMFORT. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 8201473 ↗
• MalfunctionNov 7, 2018Break; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PART OF THE CATHETER WAS CUT OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047547 ↗