BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER

    MDR report key: 8292272 · Received January 31, 2019

    Report

    Report Number
    1018233-2019-00508
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Report Date
    January 31, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030437
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "DIRECTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. 1. OPEN CSR WRAP TO FORM STERILE FIELD. 2. PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. 3. PUT ON CUFFED GLOVES. 4. POSITION DRAPE ON PATIENT. 5. REMOVE TOP TRAY. 6. LUBRICATE CATHETER. 7. PREP PATIENT WITH POVIDONE-IODINE SWABSTICKS. 8. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 9. IF SPECIMEN IS REQUIRED, FILL STERILE CONTAINER FROM CATHETER. 10. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. 11. IF URINE IS PLACED IN SPECIMEN JAR: A. SECURE CAP. B. LABEL SPECIMEN JAR. C. SEND SPECIMEN TO LABORATORY. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2010 C. R. BARD, INC. ALL RIGHTS RESERVED. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP¿ TRAY IN PLACE." THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERMITTENT CATHETER TRAY WAS MISSING COTTON BALLS, LUBRICANT AND TONGS. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87612 BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER INTERMITTENT CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772417 NGCR4533 00801741030437

    Patients

    Seq Age Sex Outcome Treatment
    1