BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 6078446 · Received November 2, 2016

    Report

    Report Number
    MW5065797
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLE WOULD NOT ASPIRATE,THEN WHEN REMOVED, SHEATH FELL OFF. SEEMS TO HAVE A HOLE SOMEWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725717 TRANSBRONCHIAL ASPIRATION NEEDLE EXCELON EOQ BOSTON SCIENTIFIC 19539608

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR