Bard® Urethral Catheterization Tray with Plastic Catheter 772514Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741030444), received between Aug 14, 2017 and May 27, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Component Missing” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WAS AIR LOCKED OR VAPOR LOCKED AS IT WOULD NOT DRAIN URINE. ALL THE ONES THAT WERE TRIED ARE FROM LOT # NGEY2221 WHEN THEY TRIED ONE FROM ANOTHER LOT NUMBER IT SEEMED TO WORK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894652 ↗
• MalfunctionFeb 16, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE YELLOW LABEL ON SOME DEVICES STATED THAT THERE WAS NO STERILE GLOVES IN KIT, WHICH WAS NOT READILY APPARENT TO THE HEALTH CARE PROFESSIONAL DURING USE. THIS CAUSED THE PATIENT TO BE RE-POSITIONED AND LEFT TO FIND GLOVES AND THEN START THE PROCESS OVER, HENCE THE PROCEDURE WAS DELAYED. THE PATIENT HAD RESTRICTED SUPINE POSITION DUE TO SPINAL SACRECTOMY AND PRESENCE OF JACKSON-PRATT DRAINS ON BACK. POSITIONING AND REPOSITIONING HAPPENED MULTIPLE TIMES DUE TO MISSING GLOVES IN KIT. ALSO REPORTEDLY, THE KIT WAS MISSING LUBRICATION FOR CATHETER AND SO AN ADDITIONAL KIT HAD TO BE OPENED TO FIND LUBRICATION.

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

  MAUDE report 11333260 ↗
• MalfunctionOct 27, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY CATHETERS HAD CHANGED LENGTH FROM 16. PER TROUBLESHOOTING, THE MSS NOTICED THAT THERE WERE NO DESIGN CHANGED FEMALE AND PEDIATRIC LENGTHS ARE CLEARLY MARKED ON THE PACKAGING AS PER THE FOLLOW UP VIA EMAIL ON 01OCT2020 ,THE ANOTHER PRODUCT CATALOG NUMBER RECEIVED WITH SAME ISSUE.

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

  MAUDE report 10741670 ↗
• MalfunctionJun 10, 2020Component Missing

  IT WAS REPORTED THAT THE IODINE SWABS IN THE URETHRAL CATHETERIZATION TRAYS WERE MISSING.

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

  MAUDE report 10137135 ↗
• MalfunctionJul 19, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE IODINE SWABSTICKS AND LATEX GLOVES WERE MISSING FROM THE TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808612 ↗
• MalfunctionMar 18, 2019Break; Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TIP OF THE CATHETER INSIDE OF THE URETHRAL CATHETER TRAY WAS DAMAGED.

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

  MAUDE report 8428490 ↗
• MalfunctionDec 6, 2018Component Missing

  IT WAS REPORTED THAT THE TRAY DID NOT INCLUDE THE POVIDONE IODINE POUCH; HOWEVER, THE ORANGE LABEL ON THE OUTSIDE OF THE TRAY NOTED THAT THE POVIDONE IODINE POUCH WAS INCLUDED IN THE TRAY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8137306 ↗
• MalfunctionNov 16, 2018Break; Break; Material Puncture/Hole

  IT WAS REPORTED THAT A SMALL PINHOLE WAS FOUND IN THE CATHETER DURING PLACEMENT. THE HOLE WAS LOCATED UNDER THE ORANGE COLLAR LOCATED AT THE TOP OF THE CATHETER.

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

  MAUDE report 8081975 ↗
• MalfunctionOct 31, 2018Component Missing; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE FOLLOWING COMPONENTS; (1) DRAPE / (1) UNDERPAD / (1) FORCEPS / (5) RAYON BALLS / (1)LABEL / (1) POVIDONE-IODINE SOLUTION PACKET WERE MISSING FROM THE CATHETER TRAY PRIOR TO USE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Diaphoresis; No Consequences Or Impact To Patient

  MAUDE report 8025525 ↗
• MalfunctionOct 22, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETERS WERE MISSING FROM THE CATHETER TRAY.

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

  MAUDE report 7993771 ↗
• MalfunctionOct 16, 2018Compatibility Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT COTTON BALLS WERE PACKAGED INSIDE THE TRAY INSTEAD OF THE SWAB STICKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971505 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER INSIDE THE TRAY WAS KINKED.

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

  MAUDE report 7895328 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER INSIDE THE TRAY WAS KINKED.

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

  MAUDE report 7895321 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER INSIDE THE TRAY WAS KINKED.

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

  MAUDE report 7895319 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER INSIDE OF THE TRAY WAS KINKED.

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

  MAUDE report 7894223 ↗
• MalfunctionSep 17, 2018Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PATIENT HAD A KINKED CATHETER. THE PATIENT ALLEGEDLY EXPERIENCED PAIN. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 7880985 ↗
• MalfunctionJun 8, 2018Leak/Splash; Torn Material

  BARD LATEX-FREE URETHRAL CATHETERIZATION TRAY WITH PRE-CONNECTED BAG MALFUNCTIONED WHEN RN WAS PERFORMING STRAIGHT CATHETERIZATION ON PATIENT. COLLECTION BAG LEAKED AROUND AIR VENT R/T TEAR IN PLASTIC. THIS WAS REPORTED TO ME BY THE RN USING THE KIT. RN ALSO SHARED THAT THE PATIENT STATED THAT A SIMILAR LEAK HAD HAPPENED PREVIOUSLY WHEN ANOTHER RN PERFORMED A STRAIGHT CATHETERIZATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7582035 ↗
• MalfunctionAug 14, 2017Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT UPON RIPPING THE CORNER TO EMPTY THE DRAIN BAG, URINE SPLASHED IN THE NURSE'S FACE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 6791894 ↗