Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741030574), received between Sep 20, 2018 and Dec 28, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TIPS WERE MISSING ON 6 CATHETERS. THE CUSTOMER STATED THAT THE TIPS WERE MISSING ON THREE AND THE FOURTH ONE WAS USED BUT THERE WERE BUBBLES IN IT. THE CUSTOMER ALSO STATED THAT THEY DID NOT KNOW THERE WAS AN ISSUE UNTIL THEY GOT TO USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061249 ↗
• MalfunctionDec 27, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE TIPS WERE MISSING ON 6 CATHETERS. CUSTOMER STATED THAT THE TIPS WERE MISSING ON THREE AND THE FOURTH ONE WAS USED BUT THERE WERE BUBBLES IN IT. CUSTOMER ALSO STATED THAT THEY DID NOT KNOW THERE WAS AN ISSUE UNTIL THEY GOT TO USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051281 ↗
• MalfunctionDec 6, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT THE 6 INTERMITTENT CATHETER WERE MISSING THE INSERTION TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923562 ↗
• MalfunctionJul 8, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT SOME OF THE BARD TOUCHLESS PLUS INTERMITTENT CATHETERS IN THE KITS WERE DRIED OUT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962077 ↗
• MalfunctionDec 30, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE HOLES AT THE END OF THE INTERMITTENT CATHETERS WERE NOT PUNCTURED, WHICH AS A RESULT WAS NOT ALLOWING THE FLUID TO FLOW THROUGH. ALSO STATED THAT THE LABEL AFFIXED ON THE OUTSIDE OF THE PACKAGING WAS VERY CONFUSING AS TO WHAT COMPONENTS WERE STERILE ESPECIALLY WHEN THE CUSTOMER WAS TRYING TO KEEP THE ENVIRONMENT STERILE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119634 ↗
• MalfunctionDec 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE HOLES AT THE END OF THE INTERMITTENT CATHETERS WERE NOT PUNCTURED, WHICH AS A RESULT WAS NOT ALLOWING THE FLUID TO FLOW THROUGH. ALSO STATED THAT THE LABEL AFFIXED ON THE OUTSIDE OF THE PACKAGING WAS VERY CONFUSING AS TO WHAT COMPONENTS WERE STERILE ESPECIALLY WHEN THE CUSTOMER WAS TRYING TO KEEP THE ENVIRONMENT STERILE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119546 ↗
• MalfunctionJun 19, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CATHETERS GONE IN BUT THE TUBE GETS CLOGGED AND URINE COULD NOT CAME OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174490 ↗
• MalfunctionFeb 7, 2020Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS HAD VERY LITTLE LUBRICANT ON THEM, WHICH MADE THEM DIFFICULT TO INSERT. THE PATIENT WAS ABLE TO FULLY INSERT THE CATHETER WITH THE USE OF A PERSONAL LUBRICANT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9681228 ↗
• MalfunctionAug 26, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY, WHICH CAUSED FRICTION AND PAIN TO THE CUSTOMER.

  Patient problems: Pain

  MAUDE report 8930782 ↗
• MalfunctionSep 20, 2018Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED FROM THE TOP OF THE BAG, IMMEDIATELY AFTER ALLEGED CORRECT PLACEMENT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7894824 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, AFTER INSERTION OF THE CATHETER INTO THE PATIENT, THE CATHETER KINKED WHEN THE PATIENT WAS REPOSITIONED TO TRY TO AVOID THE CATHETER LEAKAGE ISSUE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7894816 ↗