BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE

    MDR report key: 1427305 · Received July 21, 2009

    Report

    Report Number
    1427305
    Event Type
    Malfunction
    Date Received
    July 21, 2009
    Date of Event
    June 9, 2009
    Report Date
    July 21, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    SEPTUM (AFTER ANALYSIS BY MFT) WAS OFF BY A MM AND NEEDLE PUNCTURE CAUSED HOLE THAT CAUSED LEAK OF CHEMO AGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE CLOSED LUER ACCESS DEVICE FMF BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 385100 8331940

    Patients

    Seq Age Sex Outcome Treatment
    1 * CHEMOTHERAPY| CHEMOTHERAPY