BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 7788578 · Received August 16, 2018

    Report

    Report Number
    7788578
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 17, 2018
    Report Date
    July 23, 2018
    Manufacturer
    C. R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BARD URETHRAL CATHETERIZATION TRAY, REF 772415 - 15 FR. RED RUBBER CATHETER, LOT # NGCT0643, C.R. BARD, INC, (B)(4). WE USE THIS URETHRAL TRAY TO DRAIN URINE FROM A PATIENT'S BLADDER. ON 4 TRAYS OF THE SAME LOT NUMBER, EACH TRAY WAS MISSING THE PACKAGE OF POVIDONE-IODINE SWABSTICKS (3) THAT THE NURSE NEEDS TO CLEANSE THE URINARY MEATUS BEFORE INSERTING THE BLADDER CATHETER. THIS MEANS THAT THE NURSE NEEDS TO BREAK STERILE TECHNIQUE TO SEARCH FOR THE POVIDONE-IODINE SWABSTICKS, OR OPEN ANOTHER TRAY TO GET THE ITEMS. FOUR TRAYS WERE OPENED FOR BLADDER CATHETERIZATIONS AND ALL 4 WERE MISSING THE SWABSTICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632138 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER CATHETER, UROLOGICAL KOD C. R. BARD, INC. 772415 NGCT0643

    Patients

    Seq Age Sex Outcome Treatment
    1