BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART DOSE IV SET

    MDR report key: 33052 · Received May 16, 1996

    Report

    Report Number
    MW1009114
    Event Type
    Malfunction
    Date Received
    May 16, 1996
    Date of Event
    May 9, 1996
    Manufacturer
    RIVER MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TUBING LEAKED AT "SEALED" POINT WHERE TUBING CONNECTS TO THE LUER LOCK AT PT'S END LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART DOSE IV SET IV SET FPA RIVER MEDICAL, INC. 5020082

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other