Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Coude Urethral Catheter 4A8114Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741046476), received between Jul 3, 2019 and Jan 30, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT FEW OF PATIENT LAST ORDERS THEY HAD ISSUES WITH THEIR INTERMITTENT CATHETER WHERE AT LEAST 1-2 KITS PER DAY THEY WERE NOT LUBRICATED ENOUGH, AND PATIENT HAD SOME BLEEDING WITH FORCING IT IN AND HAD TO TOSS THEM AWAY. THIS CAUSED SOME ISSUES BECAUSE PATIENT WOULD RUN LOW ON THEIR PRODUCT. PATIENT DID CATHETERIZE 6 PER DAY UTILIZED THESE KITS. PATIENT WAS REALLY WORRIED THEY WOULD RUN OUT OF SUPPLY BEFORE THEIR NEXT ORDER WHICH WAS NOT DUE UNTIL (B)(6) 2024. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18606918 ↗
• MalfunctionSep 3, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BOX OF 31 DRAIN BAGS AND THE INSTRUCTION FOR USE WAS MISSING INSIDE THE BOX. PER FOLLOW UP CALL ON (B)(6) 2021, CUSTOMER STATED THAT THE INSTRUCTION FOR USE WAS NOT INSIDE THE SHIPMENT AND THEY WERE CONFUSED ON HOW TO USE THE DRAIN BAG, BUT SINCE THEY HAVE BEEN ABLE TO USE THE BAGS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425338 ↗
• MalfunctionSep 23, 2020Difficult to Insert; Component Missing

  IT WAS REPORTED THAT THE COUDE INDICATOR BUMP WAS MISSING IN THE TOUCHLESS PLUS INTERMITTENT CATHETER WHICH MADE THE CATHETER DIFFICULT TO INSERT. WHEN THE USER WOULD GET THE CATHETER IN, THE CATHETER SCRATCHED THE PATIENT'S URETHRA AND RESULTED IN BLEEDING. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 10573431 ↗
• MalfunctionJul 3, 2019Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE TOUCHLES PLUS COUDE CATHETER LEAKED DURING INSERTION FROM AN UNKNOWN AREA.

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

  MAUDE report 8757584 ↗