BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADDITIV PRIMARY IV SET

    MDR report key: 46770 · Received November 5, 1996

    Report

    Report Number
    MW1010215
    Event Type
    Malfunction
    Date Received
    November 5, 1996
    Date of Event
    October 28, 1996
    Report Date
    November 1, 1996
    Manufacturer
    MC GAW, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO PRIME TUBING WITH MEDICATION BUT UNABLE. HAD TWO FAILED TUBINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADDITIV PRIMARY IV SET INTRAVENOUS ADMINISTRATION SET FPA MC GAW, INC. * F50247

    Patients

    Seq Age Sex Outcome Treatment
    1 0 * Other