BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 10835597 · Received November 13, 2020

    Report

    Report Number
    10835597
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 11, 2020
    Manufacturer
    METRIX COMPANY, THE
    Product Code
    KPE
    UDI-DI
    00812496011725
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE CAP OF THE SECURE EMPTY EVA BAG IS FUSED WITH THE PORT OF THE BAG. UNABLE TO TWIST OFF THE CAP TO FILL. THE INTENDED PROCEDURE IS TO UNCAP THE BAG AND CONNECT IT TO THE EM2400 COMPOUNDER TO PUMP INGREDIENTS INTO. NO PATIENT INVOLVED. THE DAMAGED BAG WAS FOUND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301823 SECURE CONTAINER, I.V. KPE METRIX COMPANY, THE 66225 A6753 00812496011725

    Patients

    Seq Age Sex Outcome Treatment
    1