Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter 4A6146Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741046445), received between Jun 4, 2019 and Mar 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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 17, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED BY THE PATIENT THAT SOME TOUCHLESS CATHETERS DID NOT GO IN RIGHT. IT WAS NOTED THAT A COUPLE OF CATHETERS ON THE LAST ORDER WERE NOT SLICK ENOUGH. PER FOLLOW UP WITH THE PATIENT VIA PHONE ON (B)(6) 2021 IT WAS STATED THAT THE CATHETERS WERE DIFFICULT TO INSERT SEEMED TO NOT HAVE ANY LUBRICANT ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505868 ↗
• MalfunctionJun 23, 2020Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE TOUCHLESS CATHETERS WERE BENT.

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

  MAUDE report 10185172 ↗
• MalfunctionJun 4, 2019Incorrect Measurement; Incorrect Measurement; Material Deformation

  IT WAS REPORTED THAT THE PATIENT ADVISED THAT SOME OF THE CATHETERS SEEMED TO BE SHORTER THAN NORMAL. THE PATIENT WAS ABLE TO VOID WITH CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8669177 ↗