BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPUJECT

    MDR report key: 2171128 · Received July 12, 2011

    Report

    Report Number
    2171128
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 12, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN TRANSPORT VIA HELICOPTER FROM ONE HOSPITAL TO ANOTHER AFTER A MOTOR VEHICLE ACCIDENT. PATIENT REQUIRED SEDATION DUE TO AGITATED STATE. PROVIDER ADMINISTERED TWICE THE INTENDED AMOUNT DUE TO THE DIFFICULTY ENGAGING THE SCREW-IN END OF THE CARPUJET TO THE VIAL OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPUJECT PISTON, SYRINGE, GLASS FMF HOSPIRA, INC. * RL3281

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR