BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG DC

    MDR report key: 7533647 · Received May 22, 2018

    Report

    Report Number
    7533647
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDIMOP MEDICAL PROJECTS LTD (WEST PHARMACEUTICAL SERVICES
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BAG TO VALVE LEAKED. PHOTOS ARE NOT THE EXACT DEVICE USED, MEANING THE PACKAGING WAS NOT KEPT. IT IS THE DEVICE JUST NOT THE CORRECT LOT NUMBER AND EXPIRATION DATE HENCE THE UDI WAS NOT UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376824 VIAL2BAG DC SET, I.V. FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD (WEST PHARMACEUTICAL SERVICES 6070111

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO