BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART DOSE INFUSION DEVICE

    MDR report key: 23856 · Received July 28, 1995

    Report

    Report Number
    MW1006581
    Event Type
    Malfunction
    Date Received
    July 28, 1995
    Date of Event
    July 14, 1995
    Report Date
    July 14, 1995
    Manufacturer
    RIVER MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RETURNED FAULTY DEVICE TO OFFICE. START BUTTON WAS PUNCTURED WHEN ACTIVATED. PT ALSO REPORTED THAT TWO DEVICES HAVE HAD LEAKAGE OF THE BLUE SOLUTION, LOCATED IN THE START BUTTON, INTO THE CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART DOSE INFUSION DEVICE INFUSION DEVICE MEB RIVER MEDICAL, INC. 4120208

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR