BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXA EXACTA MIX 2400 VALVE SET 24 PORT ASSEMBLY

    MDR report key: 755533 · Received June 8, 2005

    Report

    Report Number
    MW1035667
    Event Type
    Malfunction
    Date Received
    June 8, 2005
    Date of Event
    June 8, 2005
    Report Date
    June 8, 2005
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HUMAN HAIR DETECTED IN SINGLE USE IV DEVICE PACKAGE. PROBLEMS NOTED WITH IV SETUP OVER PREVIOUS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXA EXACTA MIX 2400 VALVE SET 24 PORT ASSEMBLY TPN COMPOUNDER TUBING KPE BAXA CORPORATION REF 724 169362

    Patients

    Seq Age Sex Outcome Treatment
    1 *