Bard® Urethral Catheterization Tray with Red Rubber Catheter 772414Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741030406), received between Jun 6, 2017 and May 9, 2022 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Component Missing” (9 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT THE TRAY (MATERIAL# - 772417) AND THE WAY IT WAS PACKAGED. STATED THAT THREE TRAYS HAVE BEEN LIKE THIS SO FAR (MATERIAL# 772417-LOT# UNK). ALSO STATED THAT THE SUBSTITUTE URETHRAL CATHETER TRAY HAD THE STERILE GLOVES LOCATED UNDER THE DRAPE WHICH AS A RESULT ONE WAS UNABLE TO STERILELY PLACE THE DRAPE UNLESS THE NURSE GRABBED THEIR OWN SET OF GLOVES (MATERIAL# 772414-LOT# NGFZ3767).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336927 ↗
• MalfunctionDec 4, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT TWO TRAYS DID NOT CONTAIN THE IODINE SWABSTICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10946101 ↗
• MalfunctionDec 4, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT TWO TRAYS DID NOT CONTAIN THE IODINE SWABSTICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10945938 ↗
• MalfunctionNov 24, 2020Short Fill; Short Fill

  IT WAS REPORTED THAT THE KIT DID NOT CONTAIN ANY POVIDONE SWABS AND ALSO THEY WERE DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10892621 ↗
• MalfunctionNov 24, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE KIT DID NOT CONTAIN ANY POVIDONE SWABS AND ALSO THEY WERE DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10889669 ↗
• MalfunctionMay 19, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; No Flow

  IT WAS REPORTED THAT THE CATHETERS DID NOT DRAIN URINE.

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

  MAUDE report 10069542 ↗
• MalfunctionMay 19, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; No Flow

  IT WAS REPORTED THAT THE CATHETERS DID NOT DRAIN URINE.

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

  MAUDE report 10069534 ↗
• MalfunctionJan 8, 2020Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER INSERTED WITH NO URINE OUTPUT. THE CATHETER WAS REPORTEDLY REMOVED AND REPLACED, AND THERE WAS AN 800ML URINE OUTPUT.

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

  MAUDE report 9565800 ↗
• InjuryDec 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT SHE WAS NO LONGER CATHETERIZING DUE TO RECURRENT URINARY TRACT INFECTIONS. HER DOCTOR INSTRUCTED HER TO STOP CATHETERIZING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9434158 ↗
• MalfunctionAug 15, 2019Component Missing

  IT WAS REPORTED THAT A STRAIGHT CATHETER KIT HAD MISSING PROVIDONE-IODINE SWABS. ANOTHER KIT WAS OBTAINED THAT ALSO HAD MISSING PROVIDONE-IODINE SWABS, AND BOTH KITS HAD THE SAME LOT NUMBER. BOTH KITS WERE DISCARDED AND ANOTHER WAS OBTAINED WITH NO HARM TO THE PATIENT .

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8896979 ↗
• MalfunctionJul 23, 2019Component Missing

  IT WAS REPORTED BY THE PATIENTS CAREGIVER THAT THE TRAY WAS MISSING THE BZK SWABSTICKS AND 5G LUBRICATING JELLY. THIS WAS NOTED PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 8817522 ↗
• MalfunctionJul 23, 2019Component Missing

  IT WAS REPORTED BY THE PATIENTS CAREGIVER THAT THE TRAY WAS MISSING THE BZK SWABSTICKS AND 5G LUBRICATING JELLY. THIS WAS NOTED PRIOR TO USE.

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

  MAUDE report 8815855 ↗
• MalfunctionJul 12, 2019Component Missing

  IT WAS REPORTED THAT THE IODINE SWABSTICKS WERE MISSING FROM THE URETHRAL CATHETER TRAY.

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

  MAUDE report 8784406 ↗
• MalfunctionApr 25, 2019Component Missing

  IT WAS REPORTED THAT THE CATHETER AND THE PREP KIT WAS MISSING FROM THE CATHETER TRAY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8551968 ↗
• InjuryJan 4, 2019Patient-Device Incompatibility; Manufacturing, Packaging or Shipping Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION FOLLOWING USE OF THE CATHETER. THE TRAY WAS MANUFACTURED WITHOUT THE POVIDONE-IODINE PRE-SATURATED SWABSTICKS DUE TO A MARKET WIDE SHORTAGE. THE PATIENT ALLEGEDLY FELT THAT THE LACK OF POVIDONE-IODINE PRE-SATURATED SWABSTICKS WITHIN THE TRAY CONTRIBUTED TO THE URINARY TRACT INFECTION. THE UTI WAS REPORTEDLY TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8216817 ↗
• MalfunctionNov 1, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETER KIT WAS MISSING THE RED RUBBER CATHETER PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 8027912 ↗
• MalfunctionJun 18, 2018Partial Blockage; No Flow; Partial Blockage

  IT WAS REPORTED THAT NO URINE DRAINED INTO THE BAG FROM THE INTERMITTENT CATHETER. THE CATHETER WAS REMOVED, AND ALLEGEDLY FELT LIKE THERE WAS A "MEMBRANE COVERING THE EYELETS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7610108 ↗
• MalfunctionOct 17, 2017No Device Output

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DRAIN THE URINE. THE COMPLAINANT ALLEGED THAT THE PATIENT EXPERIENCED INCONTINENCE IMMEDIATELY UPON REMOVAL OF CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Incontinence

  MAUDE report 6954067 ↗
• MalfunctionOct 17, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DRAIN THE URINE. THE COMPLAINANT ALLEGED THAT THE CATHETER WAS COMPLETELY INSERTED AND THE PATIENT STILL COULD NOT VOID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Information

  MAUDE report 6954065 ↗
• MalfunctionOct 17, 2017No Flow

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DRAIN THE URINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6954064 ↗
• MalfunctionJun 6, 2017Leak/Splash

  IT WAS REPORTED THAT THE IODINE SWAB PACKET LEAKED INTO THE TRAY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6616100 ↗