Bard® Rubber Utility Catheter 277712Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741034091), received between Jun 11, 2021 and May 5, 2023 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE FOREIGN BODY CONTAMINATION APPEARS TO BE BROKEN TIP OF ANOTHER URETHRAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875941 ↗
• MalfunctionMar 13, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT FOUND A WHITE POWDER LIKE SUBSTANCE ON ONE INTERMITTENT CATHETER AND DID NOT WANT TO TRY TO USE. THE REPRESENTATIVE ADVISED TO REPLACE THAT CATHETER AND TO HOLD ON TO IT AS THE MANUFACTURER MAY WANT TO HAVE IT. PER CUSTOMER VIA PHONE ON (B)(6)2022, IT WAS REPORTED THAT THERE WAS WHITE SUBSTANCE OR POWDER ON THE CATHETER. PER SAMPLE EVALUATION ON (B)(6)2023, IT WAS NOTED THAT THERE WERE NO EYELETS ON THE INTERMITTENT CATHETER DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528932 ↗
• MalfunctionJun 21, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT HAD BLEEDING AND THE INTERMITTENT CATHETER CLOGS UP AT TIMES ABOUT EVERY TWO WEEKS. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP CALL ON (B)(6) 2022, STATED THAT THE PATIENT STILL HAD MILD BLEEDING AND THE PATIENT NOTIFIED THIS TO THE DOCTOR. DOCTOR TOLD THAT THE MILD BLEEDING WAS FINE AND NO ISSUES WITH CLOGS AND THE PATIENT WAS USING STRAIGHT TIP CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14756793 ↗
• InjuryMar 4, 2022Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT DID NOT LIKE THE WAY THE USER HAD TO PUT THE LUBRICANT ON SOMETHING TO LUBRICATE THE INTERMITTENT CATHETERS. THE PATIENT WAS ALSO GETTING MORE INFECTIONS. THE REPRESENTATIVE RECOMMENDED TO USE GLOVES AND TO TRY DIFFERENT TECHNIQUES. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13670204 ↗
• MalfunctionDec 30, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE RED RUBBER CATHETER HAD IRRITATED THE PATIENT'S URETHRA AND MADE THE WITHDRAWAL DIFFICULT. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 05NOV2021, PATIENT STATED THAT THE SUBBED CATHETERS WERE HURTING. PER FOLLOW-UP VIA PHONE ON 20DEC2021, IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE USED FOR 3-4 WEEKS AND IT CAUSED IRRITATION. CUSTOMER STATED THAT THE CATHETERS FINISH WAS NOT AS SMOOTH AS WHAT THEY NORMALLY USED AND THE IRRITATION CLEARED UP WITHOUT CONSULTING A DOCTOR. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 13120946 ↗
• MalfunctionNov 29, 2021Device Contamination with Chemical or Other Material; Naturally Worn; Device Contamination with Chemical or Other Material; Naturally Worn

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND THERE WERE SOME SPOTS THAT HAD WHITE STRIPES. HEALTH PROFESSIONAL ALSO STATED THAT THERE WAS DISCOLORATION AT THE NEEDLE EYE. PER FOLLOW UP ON (B)(6) 2021, IT WAS STATED THAT THE CATHETERS SHOULD HAVE BEEN RED ALL OVER, BUT IT HAD WHITE STRIPES, SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES, SOME HAD DISCOLORATION AT THE EYE OF THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP ON (B)(6)2021, CUSTOMER STATED ABOUT BREAKING DOWN AS LISTED. ALSO, CUSTOMER RESPONDED THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT WERE BREAKING DOWN AS IN LOOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12886243 ↗
• MalfunctionNov 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A STRAIGHT CATHETER WAS USED TO INSTILL BACILLI CALMETTE-GUERIN INTO THE BLADDER. STATED THAT HALFWAY THROUGH THE INSTILLATION OF 50 CC OF MEDICATION, A TINY HOLE WAS DEVELOPED IN THE CATHETER JUST IN THE NECK WHERE THE CATHETER ATTACHES TO THE 3 WAY INJECTION DEVICE. A FEW DROPS OF MEDICATION LEAKED ON TO THE PAPER DRAPE AROUND THE PENIS. USER WAS ABLE TO BLOCK THE HOLE AND INSTILL THE REST OF THE DRUG. THE PATIENT WAS THEN INSTRUCTED TO WASH THOROUGHLY WITH SOAP AND WATER AFTER IN CASE ANY DROPPED ON THE PATIENT¿S SKIN. PER EMAIL RESPONSE RECEIVED ON 13-JAN-2022, NURSE STATED THERE WAS NO WAY TO TELL HOW MUCH OF THE MEDICATION WAS LOST DUE TO THE HOLE IN THE CATHETER. NURSE STATED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884008 ↗
• MalfunctionJun 19, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND THERE WERE SOME SPOTS THAT HAD WHITE STRIPES. THE HEALTH PROFESSIONAL ALSO STATED THAT THERE WAS DISCOLORATION AT THE NEEDLE EYE. PER FOLLOW UP ON (B)(6) 2021, IT WAS STATED THAT THE CATHETERS SHOULD HAVE BEEN RED ALL OVER, BUT IT HAD WHITE STRIPES. IT WAS ALSO STATED THAT, SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES, SOME HAD DISCOLORATION AT THE EYE OF THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP ON (B)(6) 2021, CUSTOMER STATED ABOUT BREAKING DOWN THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT WERE BREAKING DOWN AS IN LOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030061 ↗
• MalfunctionJun 19, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND THERE WERE SOME SPOTS THAT HAD WHITE STRIPES. THE HEALTH PROFESSIONAL ALSO STATED THAT THERE WAS DISCOLORATION AT THE NEEDLE EYE. PER FOLLOW UP ON (B)(6) 2021, IT WAS STATED THAT THE CATHETERS SHOULD HAVE BEEN RED ALL OVER, BUT IT HAD WHITE STRIPES. IT WAS ALSO STATED THAT, SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES, SOME HAD DISCOLORATION AT THE EYE OF THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP ON (B)(6) 2021, CUSTOMER STATED ABOUT BREAKING DOWN THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT WERE BREAKING DOWN AS IN LOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030060 ↗
• MalfunctionJun 19, 2021Material Protrusion/Extrusion; Naturally Worn; Material Protrusion/Extrusion; Naturally Worn

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND THERE WERE SOME SPOTS THAT HAD WHITE STRIPES. THE HEALTH PROFESSIONAL ALSO STATED THAT THERE WAS DISCOLORATION AT THE NEEDLE EYE. PER FOLLOW UP ON 27MAY2021, IT WAS STATED THAT THE CATHETERS SHOULD HAVE BEEN RED ALL OVER, BUT IT HAD WHITE STRIPES. IT WAS ALSO STATED THAT, SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES, SOME HAD DISCOLORATION AT THE EYE OF THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP ON 27MAY2021, CUSTOMER STATED ABOUT BREAKING DOWN THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT WERE BREAKING DOWN AS IN LOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030030 ↗
• MalfunctionJun 18, 2021Material Protrusion/Extrusion; Naturally Worn; Material Protrusion/Extrusion; Naturally Worn

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND THERE WERE SOME SPOTS THAT HAD WHITE STRIPES. THE HEALTH PROFESSIONAL ALSO STATED THAT THERE WAS DISCOLORATION AT THE NEEDLE EYE. PER FOLLOW UP ON 27MAY2021, IT WAS STATED THAT THE CATHETERS SHOULD HAVE BEEN RED ALL OVER, BUT IT HAD WHITE STRIPES. IT WAS ALSO STATED THAT, SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES, SOME HAD DISCOLORATION AT THE EYE OF THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP ON 27MAY2021, CUSTOMER STATED ABOUT BREAKING DOWN THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT WERE BREAKING DOWN AS IN LOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028159 ↗
• MalfunctionJun 14, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND THERE WERE SOME SPOTS THAT HAD WHITE STRIPES. HEALTH PROFESSIONAL ALSO STATED THAT THERE WAS DISCOLORATION AT THE NEEDLE EYE. PER FOLLOW UP ON 27MAY2021, IT WAS STATED THAT THE CATHETERS SHOULD HAVE BEEN RED ALL OVER BUT IT HAD WHITE STRIPES, SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES, SOME HAD DISCOLORATION AT THE EYE OF THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP ON 27MAY2021, CUSTOMER STATED ABOUT BREAKING DOWN . CUSTOMER RESPONDED THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT WERE BREAKING DOWN AS IN LOOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996167 ↗
• MalfunctionJun 14, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LATEX INTERMITTENT CATHETER SEEMED TO BE BREAKING DOWN AND IT SHOULD BE RED BUT SOME SPOTS HAVE WHITE STRIPES. THE HEALTH PROFESSIONAL STATED THAT THERE WAS DISCOLORATION IN THE NEEDLE EYE. PER FOLLOW UP ON (B)(6) 2021 THE CUSTOMER STATED THAT THE CATHETERS SHOULD BE RED ALL OVER BUT IT HAD WHITE STRIPES SOME HAD ROUGH AREAS ON THE OPPOSITE SIDE OF THE EYES AND SOME HAD DISCOLORATION IN THE EYE OF THE NEEDLE AND PROVIDED LOT NUMBERS NGEP0919 AND NOT USED IN PATIENT. PER FOLLOW UP ON 27MAY2021 THE CUSTOMER STATED ABOUT BREAKING DOWN. THE CUSTOMER RESPONDED THAT THE TEXTURE WAS ROUGH AND NOT SMOOTH ON THE OPPOSITE SIDE OF THE NEEDLE EYE. THE CATHETERS WERE NOT BROKEN BUT BREAKING DOWN AS IN LOOSING STRUCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996084 ↗
• InjuryJun 11, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT CUSTOMER HAD URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11987148 ↗