Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5142Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741030543), received between May 26, 2017 and Jun 4, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Material Fragmentation

  IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER FOR STRAIGHT CATHETER LEFT IN PATIENT URETHRA. AS PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 21MAY2026, NO PHYSICAL SAMPLES ARE AVAILABLE. THERE WAS A RETAINED INTRODUCER IN THE PATIENT¿S URETHRA. THE INTRODUCER WAS SUCCESSFULLY REMOVED, AND THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL CARE OR INTERVENTION WAS REQUIRED BEYOND REMOVAL. WHILE NO INJURY OCCURRED, THEY DO CONSIDER THE RETENTION EVENT TO BE A HIGH CONCERN AND ARE THANKFUL THAT IT DID NOT RESULT IN PATIENT HARM. ADDITIONALLY, THIS ISSUE HAS OCCURRED IN SEVERAL PATIENTS OVER APPROXIMATELY A SIX-MONTH PERIOD, WHICH FURTHER ELEVATES OUR CONCERN. REMOVAL OF THE INTRODUCER ONLY; NO FURTHER INTERVENTION WAS NECESSARY. YES, TROUBLESHOOTING ATTEMPTED. EDUCATION HAS BEEN REINFORCED WITH STAFF, AND VENDOR ROUNDING HAS BEEN CONDUCTED TO ENSURE PROPER TECHNIQUE AND CORRECT USE OF THE DEVICE. IN ADDITION, WE HAVE REQUEST CHANGES WITH THE INNOVATIONS TEAM TO ENSURE THERE WAS NOT A REMOVABLE PIECE ON THIS PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25392325 ↗
• MalfunctionMar 23, 2026Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED BY CUSTOMER THAT THE PACKAGING OF THE TCHLESS 12 FRENCH INTERMITTENT CATHETER HAD SMALL HOLES AND THE CATHETERS BECAME NONSTERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670802 ↗
• InjuryJan 23, 2026Disconnection; Use of Device Problem

  IT WAS REPORTED THAT PLASTIC INTRODUCER CAME OFF OF STRAIGHT INTERMITTENT CATHETER AND BEEN RETAINED INSIDE PATIENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24171185 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT URINARY TRACT INFECTION EVEN WHEN USING TOUCHLESS PLUS CATHETER KITS. IT WAS STATED THAT THE SWABS INSIDE THE KIT INDICATED THEY WERE ANTISEPTIC IN NON-STERILE SOLUTION AND PATIENT SAID THAT THE SWABS WERE NOT STERILE. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Urinary Tract Infection

  MAUDE report 18465849 ↗
• InjuryDec 28, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THESE TOUCHLESS PLUS CATHETER WAS HURTING THE PATIENT WHILE GOING IN AND DID NOT VOID. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, CUSTOMER STATED THAT PATIENT HAD DEVELOPED URINARY TRACT INFECTION FROM NOT BEING ABLE TO DRAIN THE BLADDER. CUSTOMER WAS PRESCRIBED AN ANTIBIOTIC BY THE PATIENT'S DOCTOR FOR THE URINARY TRACT INFECTION. IT WAS STATED THAT THE CUSTOMER WAS NOW USING THE COLOPLAST CATHETERS AND HAD NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Tract Infection

  MAUDE report 13096268 ↗
• MalfunctionMar 23, 2021Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THE TOUCHLESS PLUS CATHETERS IN THIS SAMPLE ORDER WERE CLOGGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557227 ↗
• MalfunctionDec 15, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER DID NOT RELEASE ANY URINE OUT OF THE BLADDER AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11012927 ↗
• MalfunctionJan 20, 2020Scratched Material

  IT WAS REPORTED THAT THE TOUCHLESS PLUS CATHETER WAS SHARP AND KEPT CUTTING THE PATIENT DURING INSERTION, WHICH CAUSED THE PATIENT TO BLEED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9608330 ↗
• MalfunctionAug 27, 2018Short Fill; Appropriate Device Problem Term/Code Not Available; Short Fill

  IT WAS REPORTED THAT THE KIT DID NOT CONTAIN ENOUGH LUBRICANT GEL WITHIN THE PACKET.

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

  MAUDE report 7819581 ↗
• MalfunctionMay 26, 2017Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY TOO FLIMSY AND WAS POORLY LUBRICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6595624 ↗