Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit 4A5144Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00801741030550), received between May 10, 2017 and Sep 23, 2026 — classified as 31 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (30 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 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873289 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S WIFE STATED THAT THEY HAD BEEN USING TOUCHLESS. BUT RECENTLY, THEIR HUSBAND HAD BEEN LEAKING EVERYWHERE, AND THEY HAD AN ISSUE WITH THE PART THAT GOES INTO THE BAG. THEY WERE USING 4A5144/NGNL1999. IT WAS UNCLEAR WHAT ISSUE THE PATIENT WAS HAVING (NOTHING GOES INTO THE BAG; RATHER, THE CATHETER EXITS THE BAG). THE UROLOGIST SOUNDED LIKE THEY SUGGESTED TO TRYING A RED RUBBER VERSION. 4A2045 WAS OFFERED AS THE RED RUBBER VERSION. THE PATIENT'S WIFE STATED THAT THEY WOULD HAVE THEIR HUSBAND, CALLED INTO BD PRODUCT COMPLAINTS DIRECTLY ONCE THEY WERE RETURNS HOME AS THEY WOULD BE BETTER ABLE TO ARTICULATE THE ISSUE THEY WERE HAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060126 ↗
• MalfunctionDec 15, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT A STRAIGHT CATHETER KIT WAS REMOVED FROM THE SUPPLY ROOM TO TAKE INTO A PATIENT¿S ROOM, AND IT WAS NOTED THAT BROWN BETADINE FLUID HAD LEAKED THROUGHOUT THE KIT. UPON FURTHER INSPECTION, SEVERAL CATHETER KITS WERE FOUND IN THE SUPPLY ROOM BIN THAT HAD ALSO LEAKED BETADINE, AND SOME HAD LEAKED ALL THE WAY THROUGH THE PAPER PART OF THE PACKAGING AND HAD DRIED ON THE OUTSIDE OF THE PACKAGING. THE DAMAGED KITS WERE REMOVED FROM THE SUPPLY ROOM AND DISCARDED AFTER BEING SHOWN TO THE UNIT MANAGER AND ASSISTANT MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810831 ↗
• InjuryOct 27, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WAS STRAIGHT CATHED IN THE EMERGENCY DEPARTMENT, AND THE PIECE THROUGH WHICH THE CATHETER IS FED INTO THE URETHRA MUST HAVE COME OFF THE DEVICE AND WAS LODGED IN THE PATIENT'S URETHRA. THIS REMAINED THERE UNTIL (B)(6), WHEN THE PATIENT CALLED OUT ASKING WHEN HER STENT WAS GOING TO BE REMOVED. DUE TO NO DOCUMENTATION OF A STENT BEING PLACED WHILE INPATIENT, PRESENTED TO THE PATIENT'S ROOM AND SAW THE PLASTIC PIECE LODGED IN THE PATIENT'S URETHRA. THEY REMOVED THIS MANUALLY AND THE PATIENT EXPERIENCED RELIEF. AFTER INVESTIGATION INTO WHAT THIS PIECE OF PLASTIC COULD BE, IT WAS DISCOVERED TO BE A PIECE OF THE SPECIFIED STRAIGHT CATH EQUIPMENT USED IN THE ED. THESE ITEMS ARE NOT STOCKED ON LABOR AND DELIVERY OR ON THE MOTHER/BABY UNIT. THEY WOULD LIKE TO KNOW IS THIS A KNOWN ISSUE. THEY HAVE HAD TO REMOVE THIS FROM OTHER PATIENTS IN THE PAST. IS THERE POSSIBLY ANOTHER KIT, THEY CAN USE THAT HAS A TWIST LOCK OPTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23393805 ↗
• InjuryOct 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WAS STRAIGHT CATHED IN THE EMERGENCY DEPARTMENT, AND THE PIECE THROUGH WHICH THE CATHETER IS FED INTO THE URETHRA MUST HAVE COME OFF THE DEVICE AND WAS LODGED IN THE PATIENT'S URETHRA. THIS REMAINED THERE UNTIL ON (B)(6), WHEN THE PATIENT CALLED OUT ASKING WHEN HER STENT WAS GOING TO BE REMOVED. DUE TO NO DOCUMENTATION OF A STENT BEING PLACED WHILE INPATIENT, PRESENTED TO THE PATIENT'S ROOM AND SAW THE PLASTIC PIECE LODGED IN THE PATIENT'S URETHRA. THEY REMOVED THIS MANUALLY AND THE PATIENT EXPERIENCED RELIEF. AFTER INVESTIGATION INTO WHAT THIS PIECE OF PLASTIC COULD BE, IT WAS DISCOVERED TO BE A PIECE OF THE SPECIFIED STRAIGHT CATH EQUIPMENT USED IN THE ED. THESE ITEMS ARE NOT STOCKED ON LABOR AND DELIVERY OR ON THE MOTHER/BABY UNIT. THEY WOULD LIKE TO KNOW IS THIS A KNOWN ISSUE. THEY HAVE HAD TO REMOVE THIS FROM OTHER PATIENTS IN THE PAST. IS THERE POSSIBLY ANOTHER KIT THEY CAN USE THAT HAS A TWIST LOCK OPTION. PER ADDITIONAL INFORMATION RECEIVED ON 20NOV2025, NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23335166 ↗
• MalfunctionAug 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THE TIP WAS CRUSHED ON THE CATHETER KIT, WHEN HE REMOVED THE INTRODUCER TIP. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699822 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CUSTOMER RECEIVED A LEAKING INTERMITTENT CATHETER. AS DESCRIBED BY THE CUSTOMER, THE CASE OF THE ITEM WAS IN GOOD CONDITION WHEN THEY RECEIVED THE SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371905 ↗
• InjuryJun 24, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICATION PRESENT ON THE PRODUCT AND WAS CAUSING THE PATIENT TO HAVE IRRITATION. ADVERSE EVENT PATIENT SEEK MEDICAL ATTENTION AND WAS PRESCRIBED FINASTERIDE 5MG, HOWEVER PATIENT HAS A HISTORY OF PROSTATE CANCER IN REMISSION AND MEDICATION PRESCRIBED HAS APPEARED TO BE DIRECTLY RELATED TO THE MEDICAL CONDITION. CAUTIOUSLY DOCUMENTING. LOT#NGJX0281 AND TWO OTHER LOTS UNKNOWN. CUSTOMER STATED THAT THEY WERE SHIPPED THREE-MONTH SUPPLY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22320075 ↗
• InjuryJun 24, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICATION PRESENT ON THE PRODUCT AND WAS CAUSING THE PATIENT TO HAVE IRRITATION. ADVERSE EVENT PATIENT SEEK MEDICAL ATTENTION AND WAS PRESCRIBED FINASTERIDE 5 MG, HOWEVER PATIENT HAS A HISTORY OF PROSTATE CANCER IN REMISSION AND MEDICATION PRESCRIBED HAS APPEARED TO BE DIRECTLY RELATED TO THE MEDICAL CONDITION. CAUTIOUSLY DOCUMENTING. LOT # NGJX0281 AND TWO OTHER LOTS UNKNOWN. CUSTOMER STATED THAT THEY WERE SHIPPED THREE-MONTH SUPPLY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22320071 ↗
• MalfunctionJun 6, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT STATED THAT 13 OF THE IODINE PACKETS HAVE BUST IN THE KIT AND DAMAGED THE SUPPLIES. (PCN#: 4A5144 - LOT#: NGJZ0597 AND PCN#: 4A5144 - LOT#: UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157871 ↗
• MalfunctionJun 2, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT STATED THAT 13 OF THE IODINE PACKETS HAVE BUST IN THE INTERMITTENT CATHETER AND DAMAGED THE SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122321 ↗
• MalfunctionMay 27, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT STATED THAT 13 OF THE IODINE PACKETS HAVE BUST IN THE KIT AND DAMAGED THE SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088979 ↗
• MalfunctionFeb 18, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE TOUCH LESS PLUS CATHETER PACKAGE WAS HALFWAY DOWN THE SEAM THERE WAS SLIT AND NOTCH CUTTING IN AN INCH ON EACH SIDE AND THEY HAD FOUND THIS TO BE DIFFICULT TO OPEN. THE CUSTOMER HAD TO ALWAYS USED SCISSOR. THE PACKAGE ALSO HAD THE WRONG TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403780 ↗
• MalfunctionDec 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER CAP WAS BREAKING OFF AND NOT ALLOWING THE CATHETER TO GO BACK INTO THE BAG CAUSING URINE TO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825154 ↗
• MalfunctionOct 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SOME OF THE INTERMITTENT CATHETER'S INDUCER TIPS WERE BENT OR CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533065 ↗
• MalfunctionSep 20, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT INTERMITTENT CATHETERS THEY USE HAD VERY LITTLE LUBRICATION ON THE TIP OF THE CATHETER BUT THERE WAS NO LUBRICATION ON THE REST OF THE CATHETER. THIS MAKES FOR A VERY PAINFUL INSERTION. CUSTOMER HAD ROUGHLY 200 KITS THAT WERE DEFECTIVE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 20267393 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER JUST FOUND OUT THEY HAD A URINARY TRACT INFECTION AND HAD 2 IN THE PAST. THEY DID NOT WANT THE KIT ANYMORE SINCE 6 BOXES DID NOT CONTAIN GLOVES. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 20179559 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE NO STERILE GLOVES IN 3-MONTH SUPPLY FOR 450 INTERMITTENT CATHETER KITS AND ALREADY HAD 2 URINARY TRACT INFECTIONS FROM NOT USING THE GLOVES. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 20127194 ↗
• InjurySep 3, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT CUSTOMER HAD A PATIENT WHO GOT INTERMITTENT CATHETER KIT. CUSTOMER HAVE BEEN GETTING THIS KIT FOR YEARS FOR THEIR PATIENT AND ORDERED THROUGH CARDINAL HEALTH WITH NO ISSUES. THE LAST 2 MONTHS THOUGH, PATIENT STATED THAT THE CATHETERS HAVE NOT BEEN PRELUBRICATED LIKE THEY ALWAYS HAVE BEEN. THIS HAS ACTUALLY CAUSED PATIENT TO GO INTO THE HOSPITAL FOR 4 DAYS. CUSTOMER ORDERED 2 BOXES FROM CARDINAL AND BOTH THE SAME ISSUE. THEY WENT AHEAD AND ORDERED FROM MCKESSON AS WELL THINKING MAYBE CARDINAL GOT A LOT THAT WAS WRONG, BUT THEY WERE SAYING THAT THE BOX THEY GOT FROM MCKESSON HAD THE SAME ISSUE. CUSTOMER WAS THINKING MAYBE IF THEY ORDER JUST THE CATHETER BY ITSELF IT MAY BE CORRECT, BUT CUSTOMER DID NOT KNOW WHAT THE STOCK KEEPING UNIT OR ITEM# WAS FOR JUST THE CATHETER PORTION OF THE KIT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20126925 ↗
• InjuryAug 28, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE HOSPITAL DUE TO AN INFECTION AS THE CATHETERS WITH THE INTERMITTENT TRAY WERE NOT PRE LUBRICATED AS THEY SHOULD BE.

  Patient problems: Unspecified Infection

  MAUDE report 20085235 ↗
• InjuryAug 23, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE ANOTHER ISSUE WITH THIS ORDER. THEY JUST CALLED AND HAD TO GO TO THE HOSPITAL DUE TO AN INFECTION BECAUSE THE INTERMITTENT CATHETER THAT THEY GOT IN THE KIT NOT ONLY DID NOT HAVE THE GLOVES, BUT THE CATHETERS WERE NOT PRE-LUBRICATED LIKE THEY SHOULD BE.

  Patient problems: Unspecified Infection

  MAUDE report 20048168 ↗
• MalfunctionJul 19, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE SUPPOSED TO COME LUBRICATED HOWEVER, THEY HAD BEEN COMING IN DRY FOR THE PAST COUPLE OF MONTHS CAUSING THEM TO USE THEIR OWN LUBRICANT. PER FOLLOW UP VIA EMAIL ON 18JUL2024, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE THE ITEM ANYMORE AND THE LOT NUMBER WAS NGHY1183.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781929 ↗
• MalfunctionJul 19, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE SUPPOSED TO COME LUBRICATED HOWEVER, THEY HAD BEEN COMING IN DRY FOR THE PAST COUPLE OF MONTHS CAUSING THEM TO USE THEIR OWN LUBRICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781892 ↗
• MalfunctionJul 2, 2024Device Damaged Prior to Receipt by User; Wrong Label; Device Damaged Prior to Receipt by User; Wrong Label

  IT WAS REPORTED THAT INTERMITTENT CATHETER ORDERED WAS NOT THE PRODUCT RECEIVED, THE PACKAGING PRODUCT INFORMATION WAS CORRECT BUT UPON OPENING IT WAS INCORRECT ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654719 ↗
• MalfunctionJun 4, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD NO EYELET AND IODINE LEAKED OUT DRIED UP MISSING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED ON 17MAY2024, IT WAS REPORTED THAT ONCE THEY OPENED THE KIT, IT CONTAINED A CATHETER WITHOUT AN EYELET. THE AREA WHERE THE EYELET WAS SUPPOSED TO BE WAS JUST SMOOTH. IT WAS ALSO REPORTED THAT THE CORNER WAS MISSING OFF THE SWABS WHICH CAUSED THE BETADINE TO LEAK OUT INTO THE KIT. THE SOLUTION DID NOT SPILL ONTO ANYTHING, BUT IT WAS DRIED UP INSIDE OF THE KIT. CUSTOMER DISCARDED THE KIT AND USED ANOTHER ONE. PER CUSTOMER FOLLOW INFORMATION RECEIVED VIA PHONE ON 25JUN2024, IT WAS REPORTED THAT THE KIT WAS SEALED BUT THE IODINE LOOKED LIKE IT HAD LEAKED AND DRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459607 ↗