BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART DOSE

    MDR report key: 23281 · Received July 10, 1995

    Report

    Report Number
    MW1006447
    Event Type
    Malfunction
    Date Received
    July 10, 1995
    Date of Event
    June 8, 1995
    Report Date
    June 27, 1995
    Manufacturer
    RIVER MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PHARMACIST WAS UNABLE TO FILL THE DEVICE WITH DILUENT BECAUSE IT LEAKED OUT AS HE WAS TRYING TO FILL IT USING A SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART DOSE INFUSION DEVICE MEB RIVER MEDICAL, INC. 4120188, 4120201

    Patients

    Seq Age Sex Outcome Treatment
    1 *