Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter 4A5146Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741046438), received between Sep 25, 2018 and Mar 30, 2026 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Disconnection

  IT WAS REPORTED THAT THE DAUGHTER STATED THE CATHETERS KEPT COMING OUT, CAUSING URINE TO GO EVERYWHERE. SHE STATED THEY'RE TOO SHORT. THIS HAPPENED WITH HALF THE ORDER. PATIENT HAS NOT ORDERED THIS PRODUCT PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719645 ↗
• MalfunctionMar 13, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS KEPT COMING OUT, CAUSING URINE TO GO EVERYWHERE. SHE STATED THEY'RE TOO SHORT. THIS HAPPENS WITH HALF THE ORDER. PATIENT HAS NOT ORDERED THIS PRODUCT PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596316 ↗
• MalfunctionDec 15, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PRODUCT COMPLAINT ON PRODUCT 4A5146 FOR ONE OF THEIR PATIENTS. COMPLAINT WAS THAT SOME CATHETERS WERE UNUSABLE AND BELIEVES IT COULD BE SOMETHING WITH THE INTRODUCER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810830 ↗
• MalfunctionOct 31, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE TOUCHLESS PLUS CATHETER STICK TO THE PATIENT BLADDER WHEN TRYING TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700073 ↗
• MalfunctionApr 26, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT SOME OF THE TOUCHLESS CATHETERS SEEMED TO BE 14 FRENCH BUT THEY HAD SAME FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205823 ↗
• MalfunctionDec 21, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BETADINE SWABS WERE UPSIDE DOWN. THE PACKAGING HAD ARROWS AT THE TOP WHERE IT INDICATED AS PEEL TO OPEN. STATED THAT THE PACKAGES STAND ON THE OPPOSITE END DURING STORAGE AND FOR OPENING. CUSTOMER STATED THAT THE FOIL PACKAGE WITH BETADINE SWABS WERE INCORRECTLY PLACED WHICH CAUSED THE BETADINE TO LEAVE THE SWAB AND RUN DOWN THE STICK. WHEN THE CUSTOMER TRIED TO USE THE SWAB, THE BETADINE WAS MOSTLY DRY. THEY HAVE TO ADD BETADINE SINCE IT WAS NECESSARY. THIS HAD HAPPENED VERY REGULARLY IN THE LAST 4 CASES THEY HAVE RECEIVED. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 07DEC2021, STATED THAT THE BARD TOUCHLESS CATHETER KIT CONTAINS PACKAGES OF POVIDONE-IODINE SWAB STICKS. SOMETIMES ALL THE SHIPMENTS HAVE THESE PACKAGES TOP-DOWN FROM THE INDICATED OPENING ARROWS (LOT# NGFU0124). STATED THAT WHEN OPENED, THE IODINE RUNS DOWN THE STICK, NOT ON TO THE SWABS TO COAT THEM FOR USE. CUSTOMER STATED THAT THE NEXT SHIPMENT CONTAINING LOTS# NGFU5295, NGFV2674 WITH HALF OF THE PACKAGES WERE THAT WAY. ALSO CUSTOMER SEPARATELY STATED THE PACKAGES OF SWABS FROM THE LOT# NGFV2674 DID NOT CONTAINED IODINE, OFTEN THE SWABS DID NOT CONTAIN ENOUGH TO CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057376 ↗
• MalfunctionDec 20, 2021Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE BETADINE SWABS WERE UPSIDE DOWN. THE PACKAGING HAD ARROWS AT THE TOP WHERE IT INDICATED PEEL TO OPEN. IT WAS STATED THAT THE PACKAGES STAND ON THE OPPOSITE END DURING STORAGE AND FOR OPENING. CUSTOMER STATED THAT THE FOIL PACKAGE WITH BETADINE SWABS WERE INCORRECTLY PLACED WHICH CAUSED THE BETADINE TO LEAVE THE SWAB AND RUN DOWN THE STICK. WHEN THE CUSTOMER TRIED TO USE THE SWAB, THE BETADINE WAS MOSTLY DRY. THEY MUST ADD BETADINE SINCE IT WAS NECESSARY. THIS HAD HAPPENED VERY REGULARLY IN THE LAST 4 CASES THEY HAVE RECEIVED. PRIOR TO THESE 4 CASES THIS PROBLEM WAS RARE BUT DID HAPPEN. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 07DEC2021, STATED THAT THE BARD TOUCHLESS CATHETER KIT CONTAINS PACKAGES OF POVIDONE-IODINE SWAB STICKS. SOMETIMES ALL THE SHIPMENTS HAVE THESE PACKAGES TOP-DOWN FROM THE INDICATED OPENING ARROWS (LOT NO. NGFU0124). IT WAS STATED THAT WHEN OPENED, THE IODINE RUNS DOWN THE STICK, NOT ON TO THE SWABS TO COAT THEM FOR USE. CUSTOMER STATED THAT THE NEXT SHIPMENT CONTAINING (LOT NO. NGFU5295), (LOT NO. NGFV2674) ABOUT HALF OF THE PACKAGES WERE THAT WAY. ALSO, CUSTOMER SEPARATELY STATED THAT THE PACKAGES OF SWABS FROM THE LOT N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048993 ↗
• MalfunctionDec 20, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BETADINE SWABS WERE UPSIDE DOWN. THE PACKAGING HAD ARROWS AT THE TOP WHERE IT INDICATED PEEL TO OPEN. STATED THAT THE PACKAGES STAND ON THE OPPOSITE END DURING STORAGE AND FOR OPENING. CUSTOMER STATED THAT THE FOIL PACKAGE WITH BETADINE SWABS WERE INCORRECTLY PLACED WHICH CAUSED THE BETADINE TO LEAVE THE SWAB AND RUN DOWN THE STICK. WHEN THE CUSTOMER TRIED TO USE THE SWAB, THE BETADINE WAS MOSTLY DRY. THEY HAVE TO ADD BETADINE SINCE IT WAS NECESSARY. THIS HAD HAPPENED VERY REGULARLY IN THE LAST 4 CASES THEY HAVE RECEIVED. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 07DEC2021, STATED THAT THE BARD TOUCHLESS CATHETER KIT CONTAINS PACKAGES OF POVIDONE-IODINE SWAB STICKS. SOMETIMES ALL THE SHIPMENTS HAVE THESE PACKAGES TOP-DOWN FROM THE INDICATED OPENING ARROWS (LOT# NGFU0124). STATED THAT WHEN OPENED, THE IODINE RUNS DOWN THE STICK, NOT ON TO THE SWABS TO COAT THEM FOR USE. CUSTOMER STATED THAT THE NEXT SHIPMENT CONTAINING LOTS# NGFU5295, NGFV2674 WERE THAT WAY. ALSO CUSTOMER SEPARATELY STATED THE PACKAGES OF SWABS FROM THE LOT# NGFV2674 DID NOT CONTAINED IODINE, OFTEN THE SWABS DID NOT CONTAIN ENOUGH TO CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048837 ↗
• MalfunctionOct 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BETADINE SWABS WERE UPSIDE DOWN. THE PACKAGING HAD ARROWS AT THE TOP WHERE IT INDICATED PEEL TO OPEN. STATED THAT THE PACKAGES STAND ON THE OPPOSITE END DURING STORAGE AND FOR OPENING. CUSTOMER STATED THAT THE FOIL PACKAGE WITH BETADINE SWABS WERE INCORRECTLY PLACED WHICH CAUSED THE BETADINE TO LEAVE THE SWAB AND RUN DOWN THE STICK. WHEN THE CUSTOMER TRIED TO USE THE SWAB, THE BETADINE WAS MOSTLY DRY. THEY HAVE TO ADD BETADINE SINCE IT WAS NECESSARY. THIS HAD HAPPENED VERY REGULARLY IN THE LAST 4 CASES THEY HAVE RECEIVED. PRIOR TO THESE 4 CASES THIS PROBLEM WAS RARE BUT DID HAPPEN. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 07DEC2021, STATED THAT THE BARD TOUCHLESS CATHETER KIT CONTAINS PACKAGES OF POVIDONE-IODINE SWAB STICKS. SOMETIMES ALL OF THE SHIPMENTS HAVE THESE PACKAGES TOP-DOWN FROM THE INDICATED OPENING ARROWS LOT# NGFU0124. STATED THAT WHEN OPENED, THE IODINE RUNS DOWN THE STICK, NOT ON TO THE SWABS TO COAT THEM FOR USE. CUSTOMER STATED THAT THE NEXT SHIPMENT CONTAINING LOTS# NGFU5295, NGFV2674 ABOUT HALF OF THE PACKAGES WERE THAT WAY. ALSO CUSTOMER SEPARATELY STATED THE PACKAGES OF SWABS FROM THE LOT# NGFV2674 DID NOT CONTAINED IODINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683725 ↗
• InjurySep 10, 2021Biocompatibility; Improper Chemical Reaction; Biocompatibility; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT HAD 2 URINARY TRACT INFECTIONS WITHIN THE LAST MONTH BY USING THE INTERMITTENT CATHETER. PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12453457 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BARD PRE-LUBRICATED VINYL URETHRAL CATHETERS WERE LEAKING WHILE REMOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131206 ↗
• InjuryJan 19, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE TOUCHLESS PLUS KIT PACKAGE HAD A LABEL STATING THAT THE POVIDONE-IODINE WAS NO LONGER PROVIDED STERILE. THE PATIENT DEVELOPED 3 URINARY TRACT INFECTIONS AFTER THE POVIDONE-IODINE WAS NOTED TO NO LONGER BE STERILE. THE PATIENT WAS HOSPITALIZED FOR ONE OF THE THREE INFECTIONS. PER FOLLOW UP VIA PHONE ON 06JAN2021, THE CUSTOMER WAS IN THE HOSPITAL ON IV ANTIBIOTICS FOR 4 DAYS WHEN THE PATIENT WAS HOSPITALIZED FOR 1 OF THE 3 INFECTIONS. THE OTHER 2 INFECTIONS WERE TREATED WITH PRESCRIBED ANTIBIOTICS.

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

  MAUDE report 11194693 ↗
• InjuryJan 19, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE TOUCHLESS PLUS KIT PACKAGE HAD A LABEL STATING THAT THE POVIDONE-IODINE WAS NO LONGER PROVIDED STERILE. THE PATIENT DEVELOPED 3 URINARY TRACT INFECTIONS AFTER THE POVIDONE-IODINE WAS NOTED TO NO LONGER BE STERILE. THE PATIENT WAS HOSPITALIZED FOR ONE OF THE THREE INFECTIONS. PER FOLLOW UP VIA PHONE ON 06JAN2021, THE CUSTOMER WAS IN THE HOSPITAL ON IV ANTIBIOTICS FOR 4 DAYS WHEN THE PATIENT WAS HOSPITALIZED FOR 1 OF THE 3 INFECTIONS. THE OTHER 2 INFECTIONS WERE TREATED WITH PRESCRIBED ANTIBIOTICS.

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

  MAUDE report 11194096 ↗
• InjuryNov 17, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS NOT GOING TO USE THE TOUCHLESS KIT BECAUSE OF EXPERIENCING SEPSIS DURING THE SAME TIME WHILE USING IT JUST LIKE BEFORE. THE LIBERATOR REPRESENTATIVE DID NOT PROVIDE THE 4A5146 TO THE PATIENT SINCE 2018. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR SEPSIS.

  Patient problems: Sepsis

  MAUDE report 10853892 ↗
• MalfunctionJun 5, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; Obstruction of Flow

  IT WAS REPORTED THAT THE KIT DID NOT WORK WELL WHILE DRAINING THE BLADDER WHEN ON BED.

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

  MAUDE report 10122904 ↗
• InjuryFeb 1, 2019Difficult to Insert; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DURING THE INSERTION OF THE CATHETER AND WAS UNABLE TO FULLY INSERT FOR USE. THE PATIENT ALSO ALLEGED THAT THE CATHETERS WERE THE CAUSE OF UTI'S (URINARY TRACT INFECTIONS).

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 8297473 ↗
• MalfunctionJan 2, 2019Difficult to Insert; Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER WAS NOT LUBRICATED ENOUGH, WHICH ALLEGEDLY MADE IT DIFFICULT TO INSERT. ALLEGEDLY, THE CATHETER FOLDS OVER ONCE FORCE WAS APPLIED WHEN ATTEMPTING TO INSERT.

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

  MAUDE report 8210106 ↗
• MalfunctionJan 2, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE EYELETS WERE MISSING FROM THE TOUCHLESS PLUS CATHETER.

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

  MAUDE report 8209723 ↗
• MalfunctionJan 2, 2019Misassembled; Defective Device; Misassembled

  IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO USE THE TOUCHLESS PLUS CATHETER AND THEN NOTICED THERE WAS ONLY ONE EYELET.

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

  MAUDE report 8208373 ↗
• MalfunctionSep 25, 2018Component Missing

  IT WAS REPORTED THAT ONLY THE CATHETER WAS INCLUDED IN THE KIT; THE REST OF THE ITEMS WERE MISSING.

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

  MAUDE report 7905597 ↗