Bard® Touchless® Plus Unisex Pre-Lubricated Rubber Urethral Catheter Kit 4A7044Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00801741030536), received between Sep 24, 2017 and Apr 25, 2024 — classified as 4 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (14 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT SOME OF THE PRE- LUBRICATED RUBBER URETHRAL CATHETERS WERE LUBRICATED, AND SOME WERE NOT. PER CUSTOMER ON (B)(6) 2024, IT WAS REPORTED THAT SOME OF THE CATHETERS WERE NOT LUBRICATED ENOUGH TO BE USED PROPERLY. CUSTOMER HAS SWITCHED TO A DIFFERENT COMPANY WITH CATHETERS THAT WORK BETTER FOR THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180524 ↗
• MalfunctionFeb 26, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT SOME OF THE PRE- LUBRICATED RUBBER URETHRAL CATHETERS WERE LUBRICATED, AND SOME WERE NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776650 ↗
• MalfunctionAug 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PRE LUBRICATED RUBBER URETHRAL CATHETER SUPPLIED WERE DEFECTIVE AND UNABLE TO USE. CUSTOMER STATED THAT THE TIPS WERE DEFECTIVE AND UNABLE TO INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250672 ↗
• MalfunctionOct 28, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ONE TOUCHLESS PLUS COUDE TIP INTERMITTENT CATHETER FROM A BOX OF 50 HAD NO LUBE IN IT, IT WAS NOT LIKE THE LUBE WAS DRIED OUT AND IT WAS THAT NONE WAS ADDED (LOT# NGFS1953). IT WAS STATED THAT 7 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFT2379). IT WAS ALSO STATED THAT 8 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFQ1655). PER ADDITIONAL INFORMATION ON (B)(6)2021, IT WAS STATED THAT 2 EACH FROM OF A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFR2863).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712108 ↗
• MalfunctionOct 11, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT ONE TOUCHLESS PLUS COUDE TIP INTERMITTENT CATHETER FROM A BOX OF 50 HAD NO LUBE IN IT, IT WAS NOT LIKE THE LUBE WAS DRIED OUT AND IT WAS THAT NONE WAS ADDED (LOT# NGFS1953). IT WAS STATED THAT 7 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFT2379). IT WAS ALSO STATED THAT 8 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFQ1655). PER ADDITIONAL INFORMATION ON (B)(6) 2021, IT WAS STATED THAT 2 EACH FROM OF A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFR2863).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605572 ↗
• MalfunctionOct 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ONE TOUCHLESS PLUS COUDE TIP INTERMITTENT CATHETER FROM A BOX OF 50 HAD NO LUBE IN IT. IT WAS NOT LIKE THE LUBE WAS DRIED OUT AND IT WAS THAT NONE WAS ADDED ( (LOT: NGFS1953). IT WAS STATED THAT 7 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT: NGFT2379). IT WAS ALSO STATED THAT 8 EACH FROM OF A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT: NGFQ1655). PER ADDITIONAL INFORMATION ON 07OCT2021, IT WAS STATED THAT 2 EACH FROM OF A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT: NGFR2863).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605485 ↗
• MalfunctionOct 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ONE TOUCHLESS PLUS COUDE TIP INTERMITTENT CATHETER FROM A BOX OF 50 HAD NO LUBE IN IT, ALSO IT WAS NOT LIKE THE LUBE WAS DRIED OUT AND IT WAS THAT NONE WAS ADDED (LOT# NGFS1953). IT WAS STATED THAT 7 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFT2379). IT WAS ALSO STATED THAT 8 EACH FROM A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFQ1655). PER ADDITIONAL INFORMATION ON (B)(6)2021, IT WAS STATED THAT 2 EACH FROM OF A BOX OF 50 HAD THE WHOLE TIP CURVED OVER OR FOLDED IN HALF AND IT WAS UNUSABLE (LOT# NGFR2863).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605478 ↗
• MalfunctionJul 1, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE RECEIVED SHIPMENT BOX OF THE CATHETER WAS DAMAGED AND THE TOP OF THE BOX FOLDED SHUT AND THE TAPE WAS MISSING. THE CATHETER PRESENT IN THE SHIPMENT WAS ALSO DAMAGED BUT THE CUSTOMER FELT LIKE THEY WERE INTACT TO USE BUT FOUND THAT THE LOT OF CATHETERS WERE DEFECTIVE AND THE EYELET WAS ALSO MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099555 ↗
• MalfunctionJun 30, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE INTERMITTENT COUDE CATHETERS WERE NOT CURVED ENOUGH. ALSO STATED THAT THE COUDE WAS EITHER NOT DEFINED ENOUGH OR NOT THERE AT ALL. PER FOLLOW UP ON 16JUN2021 IT WAS STATED THAT THE COUDE CATHETERS WORKS GREAT BUT 90 PERCENTAGE OF THEM DID NOT HAVE NEARLY ENOUGH COUDE TO BE EFFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093132 ↗
• MalfunctionJun 30, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE INTERMITTENT COUDE CATHETERS WERE NOT CURVED ENOUGH. ALSO STATED THAT THE COUDE WAS EITHER NOT DEFINED ENOUGH OR NOT THERE AT ALL. PER FOLLOW UP ON (B)(6) 2021 IT WAS STATED THAT THE COUDE CATHETERS WORK THEY WERE GREAT BUT 90 PERCENTAGE OF THEM DID NOT HAVE NEARLY ENOUGH COUDE TO BE EFFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092950 ↗
• MalfunctionMar 17, 2021Nonstandard Device; Material Twisted/Bent; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE COUDE WAS CURVED AND SOME JUST HAD A SLIGHT CURVE. FOLLOW UP VIA PHONE ON 26FEB2021, WHEN THE CATHETERS WEREN¿T CURVED ENOUGH, THE CUSTOMER HAD A HARD TIME INSERTING AND USING THEM. PER FOLLOW UP ON 02JUN2021, CUSTOMER STATED THAT THE COUDE TOUCHLESS CATHETER KITS HAVE VIRTUALLY NO COUDE. AS A PARAPLEGIC, THESE KITS COULD BE INVALUABLE IF THEY WERE MORE USER FRIENDLY. WHEN THE CATHETER HAD A WELL DEFINED COUDE AT LEAST 45 DEGREES, THEY WORK ALMOST 100 PERCENT OF THE TIME. PER FOLLOW UP ON 08JUN2021, CUSTOMER STATED THAT THE ISSUE WAS NOT WITH ONE PARTICULAR LOT AND IT HAD BEEN MANY LOTS OVER THE YEARS AND THE ISSUE WAS CONSTANT. ALSO ADDED THAT COUDE WAS EITHER NOT DEFINED ENOUGH OR NOT THERE AT ALL. PER FOLLOW UP ON 16JUN2021, IT WAS STATED THAT THE COUDE CATHETERS WORK GREAT, BUT 90 PERCENTAGE OF THEM DO NOT HAVE NEARLY ENOUGH COUDE TO BE EFFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510120 ↗
• MalfunctionDec 22, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS HARDLY ANY COUDE AT THE TIP OF THE CATHETER. PER FOLLOW UP VIA PHONE ON (B)(6) 2020 THE CUSTOMER NOTED THAT THE CATHETERS WERE NOT CURVED ENOUGH THEY SEEM STRAIGHT. PER FOLLOW UP ON (B)(6) 2021 THE CUSTOMER STATED THAT THE COUDE TOUCHLESS CATHETER KITS HAVE VIRTUALLY NO COUDE. AS A PARAPLEGIC THESE KITS COULD BE INVALUABLE IF THEY WERE MORE USER FRIENDLY. WHEN THE CATHETER HAD A WELL DEFINED COUDE AT LEAST 45 DEGREES. PER FOLLOW UP ON (B)(6) 2021 THE CUSTOMER STATED THAT THE ISSUE WAS NOT WITH ONE PARTICULAR LOT AND WITH MANY LOTS OVER THE YEARS AND THE ISSUE WAS CONSTANT. ALSO STATED THAT THE COUDE WAS EITHER NOT DEFINED ENOUGH OR NOT THERE AT ALL. PER FOLLOW UP ON (B)(6) 2021 IT WAS STATED THAT THE COUDE CATHETERS WORK THEY ARE GREAT BUT 90 PERCENTAGE OF THEM DID NOT HAVE NEARLY ENOUGH COUDE TO BE EFFECTIVE.

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

  MAUDE report 11060206 ↗
• MalfunctionDec 15, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT HAD NOTICED FOR SOME TIME NOW THAT THE MANUFACTURE WAS CUTTING THE CATHETERS TOO SHORT, THEY WERE SHORTER THAN THAT THEY USED.

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

  MAUDE report 11013352 ↗
• MalfunctionJul 30, 2020Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT WAS HALF WAY THROUGH A BOX OF 50 TOUCHLESS PLUS CATHETER AND HAD 2 THAT DID NOT ALLOW FLUID TO PASS.

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

  MAUDE report 10345984 ↗
• InjuryJul 16, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND THE CAUSE WAS UNKNOWN. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 10283219 ↗
• MalfunctionJul 16, 2020Improper Chemical Reaction; Material Integrity Problem; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS DID NOT HAD ENOUGH LUBRICANT.

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

  MAUDE report 10282579 ↗
• MalfunctionMay 20, 2020Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE COUDE TIP WERE NOT CURVED ENOUGH. IT WAS NOTED THAT ALL 4 CATHETERS WERE FOUND TO NOT HAVING COUDE INDICATOR BUTTON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10074229 ↗
• MalfunctionApr 2, 2020Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICATION INSIDE OF THE GEL PACKAGE. THE PATIENT STATED SOME PACKAGES ARRIVED EMPTY, AND OTHERS DID NOT HAVE ENOUGH LUBRICATION WHICH MADE IT UNCOMFORTABLE TO INSERT THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9918135 ↗
• MalfunctionMar 18, 2020Nonstandard Device; Material Deformation; Nonstandard Device

  IT WAS REPORTED THAT THE COUDE WASN'T CURVED ENOUGH. NO MEDICAL INTERVENTION.

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

  MAUDE report 9848168 ↗
• MalfunctionDec 27, 2019Misassembled; Misassembled; Component Missing

  IT WAS REPORTED THAT THE COUDE INDICATORS WERE MISSING FROM THE CATHETERS.

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

  MAUDE report 9525309 ↗
• MalfunctionDec 18, 2019Product Quality Problem; Product Quality Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE CATHETER HAD DRIED LUBRICANT.

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

  MAUDE report 9491664 ↗
• MalfunctionNov 26, 2019Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE COUDE TOUCHLESS PLUS CATHETER WAS 4 INCHES SHORTER THAN ANOTHER TOUCHLESS CATHETER.

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

  MAUDE report 9379177 ↗
• MalfunctionNov 13, 2019Misassembled; Misassembled; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS NO BUMP AT THE FUNNEL END OF THE COUDE CATHETER TO INDICATE THAT IT IS COUDE BUT THE CATHETER DID HAVE A CURVE.

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

  MAUDE report 9314619 ↗
• MalfunctionNov 7, 2019Misassembled; Misassembled; Material Deformation

  IT WAS REPORTED THAT THERE WAS NO BUMP AT THE FUNNEL END OF THE COUDE CATHETER TO INDICATE THAT IT IS COUDE BUT THE CATHETER DID HAVE A CURVE.

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

  MAUDE report 9293101 ↗
• MalfunctionOct 24, 2019Difficult to Insert; Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER APPEARED SHORTER THAN NORMAL CAUSING A DIFFICULT INSERTION PROCESS. THE PATIENT WAS UNABLE TO USE THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9234135 ↗