Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A5044Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741030512), received between Oct 30, 2017 and Jan 27, 2026 — classified as 5 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN USING THE 4A2045 KIT SUCCESSFULLY FOR AN EXTENDED PERIOD AND EXPERIENCED NO ISSUES WITH LEAKAGE OR INFECTIONS. SINCE THIS PRODUCT WAS DISCONTINUED, CUSTOMERS HAVE BEEN USING THE SUGGESTED REPLACEMENT, SKU 4A5044, WHICH WAS A UNISEX CATHETER KIT. CUSTOMER REPORTS THAT THIS ALTERNATIVE DOES NOT WORK WELL FOR THEM, NOTING THAT IT CONSISTENTLY LEAKS AND DOES NOT FUNCTION IN THE SAME WAY AS THE MALE SPECIFIC DESIGN. CUSTOMER ALSO SHARED THAT THEY HAVE TRIALED MULTIPLE SUBSTITUTE PRODUCTS OVER THE PAST FEW MONTHS, AND ALL HAVE RESULTED IN UTIS AND ADDITIONAL DIFFICULTIES, MAKING THE DISCONTINUED 4A2045 THE ONLY PRODUCT THAT RELIABLY MET THEIR CLINICAL NEEDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Urinary Tract Infection

  MAUDE report 24195904 ↗
• MalfunctionNov 26, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT STATED THE CATHETER STOPPER WAS NOT STOPPING AND CATHETER WAS COMING OUT OF THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658300 ↗
• MalfunctionNov 26, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PT SAID THAT EXCHANGING DEFECTIVE ITEM. STOPPER IS NOT STOPPING THE CATHETER FROM PULLING OUT OF THE COLLECTION BAG, REPLACING. PT CANNOT LOCATE LOT #. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657531 ↗
• MalfunctionJan 3, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER STEM WAS LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434489 ↗
• MalfunctionDec 13, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TOUCHLESS CATHETERS WERE DEFECTIVE, STEMS LONG, AND WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322589 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WOULD LIKE TO KNOW IF THERE WAS AIR IN THEIR TOUCHLESS PLUS (4A5044) PACKAGING, DID THIS MEAN IT WAS NOT STERILE. REPRESENTATIVE STATED THAT AS LONG AS THE PACKAGING WAS IN TACT, NOT DAMAGED OR OPENED, THE INSIDE REMAINS STERILE. ON (B)(6) 2023, PATIENT ADVISED THEY HAD BEEN GETTING URINARY TRACT INFECTION MORE FREQUENTLY AFTER USE. THEY STATED THAT THE CATHETER SHOULD HAVE AN 'AIR POCKET' ONCE IT WAS STERILIZED THAT COULD BE FOUND WHEN LIGHTLY PRESSED, HOWEVER, THE LAST SIX OR SEVEN THEY UTILIZED DID NOT HAVE THE AIR POCKET. PATIENT ADVISED THAT THEY FELT AIR LEAK FROM THE PACKAGING MAKING THE CATHETER NO LONGER STERILE AS BACTERIA COULD GET IN. PATIENT RECEIVED THEIR CATHETERS FROM LIBERATOR MEDICAL. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 18300132 ↗
• MalfunctionDec 6, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT WOULD LIKE TO KNOW IF THERE WAS AIR IN THEIR TOUCHLESS PLUS (4A5044) PACKAGING, DID THIS MEAN IT WAS NOT STERILE. REPRESENTATIVE STATED THAT AS LONG AS THE PACKAGING WAS IN TACT, NOT DAMAGED OR OPENED, THE INSIDE REMAINS STERILE. ON 20NOV2023, PATIENT ADVISED THEY HAD BEEN GETTING URINARY TRACT INFECTION MORE FREQUENTLY AFTER USE. THEY STATED THAT THE CATHETER SHOULD HAVE AN 'AIR POCKET' ONCE IT WAS STERILIZED THAT COULD BE FOUND WHEN LIGHTLY PRESSED, HOWEVER, THE LAST SIX OR SEVEN THEY UTILIZED DID NOT HAVE THE AIR POCKET. PATIENT ADVISED THAT THEY FELT AIR LEAK FROM THE PACKAGING MAKING THE CATHETER NO LONGER STERILE AS BACTERIA COULD GET IN. PATIENT RECEIVED THEIR CATHETERS FROM LIBERATOR MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274110 ↗
• MalfunctionMar 24, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TOUCHLESS CATHETERS WERE DIFFICULT TO INSERT BECAUSE THEY WERE TWISTED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873165 ↗
• MalfunctionFeb 14, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT FOR THE PAST FEW WEEKS THE CUSTOMER HAVE NOTICED THAT THE INTERMITTENT CATHETERS DID NOT HAVE MUCH LUBRICANT AND HAD CAUSED DIFFICULTY IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529226 ↗
• MalfunctionAug 13, 2021Moisture Damage; Moisture Damage

  IT WAS REPORTED THAT THERE WAS MOISTURE PRESENT INSIDE THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319594 ↗
• MalfunctionNov 26, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT LUBRICATED HENCE THE CATHETER WAS DIFFICULT TO INSERT. NO MEDICAL INTERVENTION REPORTED. THE PATIENT STATED IT MADE AFRAID OF INFECTION.

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

  MAUDE report 10911168 ↗
• MalfunctionNov 20, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS IN THE KITS WERE VERY DRY AND HENCE PATIENT HAD HARD TIME WITH INSERTION. STATED THAT THE PATIENT FELT PINCHING FROM INSERTION. PATIENT HAD 10 USED CATHETERS FROM THE SAME LOT THAT HAD CAUSED ISSUES. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 10877782 ↗
• InjurySep 14, 2020Improper or Incorrect Procedure or Method; Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO REUSE THE BARD TOUCHLESS PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT. ALSO STATED THAT THE PATIENT DEVELOPED URINARY TRACT INFECTION. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO URINARY TRACT INFECTION AND MEDICAL INTERVENTION WAS ALSO UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10528291 ↗
• MalfunctionMar 25, 2020Product Quality Problem; Defective Device; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. THE PATIENT STATED THAT THE LACK OF LUBRICANT MADE IT DIFFICULT TO USE, AND WOULD LIKE AN EXTRA PACKAGE OF LUBRICANT INSIDE FUTURE ORDERS.

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

  MAUDE report 9878016 ↗
• InjuryJan 8, 2020Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY, WHICH CAUSED THE CUSTOMER TO HAVE TO ADD LUBRICANT TO USE. THE PATIENT ALSO EXPERIENCED URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9565787 ↗
• MalfunctionJul 29, 2019Inaccurate Flow Rate; Inaccurate Flow Rate; No Flow

  IT WAS REPORTED THAT NO URINE WAS DRAINING FROM THE PATIENT WHILE USING THE CATHETER.

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

  MAUDE report 8836251 ↗
• MalfunctionJan 29, 2019Inaccurate Flow Rate; Patient-Device Incompatibility; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER DOES NOT DRAIN ONCE IT GETS TO THE PATIENT'S BLADDER.

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

  MAUDE report 8286085 ↗
• InjuryDec 11, 2018Patient-Device Incompatibility; Component Missing; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A URINARY TRACT INFECTION DUE TO THE POVIDONE IODINE MISSING FROM THE CATHETER TRAY. THE TRAY IS CURRENTLY BEING MANUFACTURED WITHOUT THE POVIDONE IODINE DUE TO A MARKET WIDE SHORTAGE.

  Patient problems: Urinary Tract Infection

  MAUDE report 8150284 ↗
• MalfunctionSep 25, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DRAIN AFTER INSERTION. THE CATHETER WAS REPLACED AND NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7906280 ↗
• MalfunctionSep 4, 2018Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS LESS LUBRICANT ON THE CATHETER AND MADE IT DIFFICULT TO INSERT.

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

  MAUDE report 7842673 ↗
• MalfunctionAug 5, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER SEEMS WIDER THAN USUAL, MAKING IT MORE DIFFICULT TO INSERT. REASON FOR REPORT: INVESTIGATION RESULTS. (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750528 ↗
• MalfunctionJul 24, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DRAIN AFTER INSERTION. THE CATHETER WAS REPLACED AND NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7716049 ↗
• MalfunctionJun 7, 2018Component Missing

  IT WAS REPORTED THAT THE TOUCHLESS CATHETER WAS MISSING THE INSERTION TIP.

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

  MAUDE report 7579528 ↗
• MalfunctionOct 30, 2017Difficult to Insert

  IT WAS REPORTED THAT THE CATHETER WAS DRY AND WOULD NOT LUBRICATE. ALLEGEDLY, THE PATIENT WAS ABLE TO INSERT THE CATHETER; HOWEVER, THE PATIENT EXPERIENCED PAIN. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 6988628 ↗