Bard® Clean-Cath® Intermittent Catheter 420712Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741038730), received between Aug 17, 2020 and Sep 21, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 11, 2021Class IITerminated

   The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

   Z-1431-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER CAUSED A URINARY TRACT INFECTION TO THE PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12505916 ↗
• MalfunctionMar 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WERE CONFIRMED REPORTS OF THE CATHETER TIP COULD POTENTIALLY BE CUT OFF RESULTING IN THE CATHETER POUCH SEAL HAVING AN OPENING NEAR THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446844 ↗
• MalfunctionAug 21, 2020Component Missing; Detachment of Device or Device Component; Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE TIP OF A CATHETERS WAS CLEANLY CUT OFF AND TIP WAS MISSING. ALSO STATED PATIENT EXPERIENCED BLEEDING AND PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10439606 ↗
• MalfunctionAug 17, 2020Break; Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TIP OF A CATHETERS WAS PERFECTLY CUT OFF. ALSO STATED PATIENT EXPERIENCED BLEEDING AND PAIN, FELT A SCRAPING AGAINST THE PATIENT'S URETHRA. NO MEDICAL INTERVENTION WAS REPORTED. PER SAMPLE EVALUATION DETERMINED THROUGH EVALUATION THAT THE TIP OF THE CATHETER WAS NOT FORMED PROPERLY. DURING SAMPLE EVALUATION, IT WAS DETERMINED THAT THE CUT CATHETER WAS CAUSED BECAUSE THE CATHETER WAS STICKING OUT OF THE PACKAGING DURING SEALING CAUSING A STERILE BARRIER BREACH.

  Patient problems: Blood Loss; Laceration(s); Pain; Patient Problem/Medical Problem

  MAUDE report 10414481 ↗