BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY NEEDLE KIT

    MDR report key: 5056464 · Received September 4, 2015

    Report

    Report Number
    5056464
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 31, 2015
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A LUMBAR PUNCTURE IN CLINIC TODAY. WHEN THE DOCTOR TRIED TO REMOVE THE SPINAL NEEDLE FROM THE PATIENT'S BACK, THE NEEDLE SEPARATED FROM THE HUB. THE DOCTOR WAS UNABLE TO REMOVE THE NEEDLE AT THAT TIME. NEEDLE WAS RE-ADJUSTED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588910 BIOPSY NEEDLE KIT FCG CAREFUSION 2200, INC. 0000720902

    Patients

    Seq Age Sex Outcome Treatment
    1