BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMCOR FLEXIBLES

    MDR report key: 10560840 · Received September 21, 2020

    Report

    Report Number
    3014527682-2020-00015
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 21, 2020
    Manufacturer
    AMCOR FLEXIBLES HEALTHCARE
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    WHITE FILTER CIRCLE ON VENTED BAG NOT CUT AND PLACED PROPERLY. EXPOSED INNER PACK WAS NOTED. PACK UNSTERILE. NO HARM TO PATIENT, AND NOT DELAY OF CASE. PACK REMOVED FROM FIELD AND REPLACED. THIS WAS FOUND ON ROI CPS, LLC MINOR PACK 880032019-LOT 78487S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029166 AMCOR FLEXIBLES BAG VENTED 24X24 N/S FRG AMCOR FLEXIBLES HEALTHCARE 111197B 961403

    Patients

    Seq Age Sex Outcome Treatment
    1