Bard® Touchless® Urethral Catheter Kit With Red Rubber Catheter 4A2044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741030642), received between Jan 8, 2019 and Mar 11, 2022 — classified as 2 injuries, 1 malfunction.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED A URINARY TRACT INFECTION THIS MONTH DUE TO CATHING. PATIENT SAW THE DOCTOR AND WAS PRESCRIBED MEDICATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 13735244 ↗
• InjuryDec 1, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AS A RESULT OF RED RUBBER CATHETERS. THE PATIENT WAS ON A ROUND OF ANTIBIOTICS. THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: Urinary Tract Infection

  MAUDE report 12913299 ↗
• MalfunctionJan 8, 2019Fluid/Blood Leak; Misassembled; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE PLASTIC PIECE AT THE END OF THE TOUCHLESS CATHETER WAS NOT PROPERLY SEALED TOGETHER AND CAUSED IT TO LEAK.

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

  MAUDE report 8227135 ↗