BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTAMIX 3000 ML EVA CONTAINER

    MDR report key: 11633775 · Received April 7, 2021

    Report

    Report Number
    MW5100643
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477251
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXTER'S EXACTAMIX 3000 ML TPN BAGS (LOT # 60245732) HAVE CONSISTENTLY BEEN FOUND TO LEAK AT THE SITE WHERE NURSES WOULD SPIKE THE BAG PRIOR TO INFUSING INTO A PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526623 EXACTAMIX 3000 ML EVA CONTAINER SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION H938741 60245732 00085412477251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention