Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter 4A6142Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741030598), received between Sep 17, 2020 and Mar 23, 2023 — classified as 3 malfunctions.

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

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.

• MalfunctionMar 23, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT AFTER TRYING 6 TOUCHLESS PLUS UNISEX PRE-LUBRICATED URETHRAL CATHETER KITS SAID IT DID NOT HAVE A HOLE IN THE TUBE THAT ALLOWED IT TO DRAIN. THEY HAD 100 AND USED 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16597099 ↗
• MalfunctionOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HOSE WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10752017 ↗
• MalfunctionSep 17, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WOULD NOT ABLE TO GET THE INTERMITTENT CATHETER TO PASS HIS PROSTATE. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER VIA PHONE ON 31AUG2020, THE PATIENT WAS UNABLE TO VOID WHILE USING THE CATHETER SINCE THEY COULD NOT GET IT PASS THE PROSTATE. THE CATHETER WAS REMOVED AND REPLACED SO THE PATIENT COULD VOID THE BLADDER.

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

  MAUDE report 10549200 ↗