BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANCOMYCIN 1GM

    MDR report key: 1908934 · Received November 18, 2010

    Report

    Report Number
    MW5018298
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    HOSPIRA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL VANCOMYCIN ADD-VANTAGE IVPBS ARE LEAKING. THE PRODUCTS ARE ASSEMBLED CORRECTLY AND LEAK FROM THE CONNECTION ONCE ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANCOMYCIN 1GM NONE KPE HOSPIRA 92200DD
    2 D5W ADD-VANTAGE BAG 100 ML NONE KPE HOSPIRA 87-003-JT

    Patients

    Seq Age Sex Outcome Treatment
    1