BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT LABORATORIES

    MDR report key: 305372 · Received November 16, 2000

    Report

    Report Number
    MW1020446
    Event Type
    Other
    Date Received
    November 16, 2000
    Date of Event
    November 15, 2000
    Report Date
    November 15, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IV SET HAS A DOUBLE STOPCOCK THAT EASILY FRACTURES. STOPCOCK FRACTURED AND PT LOST APPROX 300CC OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LABORATORIES PRIMARY I.V. SET FPA ABBOTT LABORATORIES * 65-065-HG-01

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other