BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER, EMPTY 500 ML CONTAINER

    MDR report key: 7818736 · Received August 24, 2018

    Report

    Report Number
    MW5079405
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    August 16, 2018
    Report Date
    August 23, 2018
    Manufacturer
    BAXTER HEALTHCARE SA.
    Product Code
    KPE
    UDI-DI
    20085412035264
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INTRAVIA 500 ML CONTAINER WAS FILLED IN THE INPATIENT PHARMACY WITH GAMUNEX C AND THE CONTENTS BEGAN LEAKING TO THE LEFT OF THE INFUSION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656474 INTRAVIA CONTAINER, EMPTY 500 ML CONTAINER CONTAINER, I. V. KPE BAXTER HEALTHCARE SA. 2B8013 DR17K13028 20085412035264

    Patients

    Seq Age Sex Outcome Treatment
    1