BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE EMPTY EVA CONTAINER

    MDR report key: 14547470 · Received May 27, 2022

    Report

    Report Number
    MW5109973
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CONTAMINANT FOUND IN EMPTY IV BAG AFTER POOLING SEVERAL IVIG PRODUCTS TOGETHER. LOTS NUMBERS INCLUDED: C21G131AAA, LE12X215AB, LE12X260AB. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196501 SECURE EMPTY EVA CONTAINER CONTAINER, I.V. KPE THE METRIX COMPANY 0535Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown