BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER 150ML

    MDR report key: 3873858 · Received May 29, 2014

    Report

    Report Number
    3873858
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC TIP RIPPED OFF OF ANTIBIOTIC BAG AND STAYED CONNECTED TO SPIKE WHEN ATTEMPTING TO REMOVE BAG FROM SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317202 INTRAVIA CONTAINER 150ML CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION N/A UR13K07123

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR