BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC

    MDR report key: 12800347 · Received November 11, 2021

    Report

    Report Number
    3014527682-2021-00019
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 11, 2021
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    GDY
    UDI-DI
    10884527016969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    RAYTEC GAUZE MISSING RADIOPAQUE MARKER ON ONE SIDE OF THE GAUZE. GAUZE WAS CONTAINED WITHIN ROI CPS, LLC CUSTOM PROCEDURE KIT-880085, LOT 21116472691. RAYTEC WAS DISCARDED AND A NEW TUB OF GAUZE WAS PULLED FROM INVENTORY. NO HARM TO PATIENT AND NO DELAY TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690228 VISTEC X-RAY DETECTABLE SPONGES, 16 PLY GDY CARDINAL HEALTH, INC. 7148 20M081262,21A140762,21C050362 10884527016969

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown