BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY THORACENTESIS 16GAX3

    MDR report key: 2087651 · Received May 12, 2011

    Report

    Report Number
    1625685-2011-00012
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    May 12, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT PROVIDED FOR EVALUATION; THEREFORE THE QUALITY OF THE BONE MARROW NEEDLE ASSEMBLY COULD NOT BE EVALUATED. HOWEVER, A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES IDENTIFIED SPECIFIC MANUFACTURING STEPS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE CONTRIBUTION OF THESE MANUFACTURING STEPS WILL BE EVALUATED IN CAPA (B)(4). ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS COMPLAINT IN AN EFFORT HEIGHTEN AWARENESS REGARDING THIS FAILURE MODE AND MINIMIZE ANY IMPACT FROM THE MANUFACTURING PROCESSES. A DEVICE HISTORY REVIEW (DHR) COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DR. (B)(6) CLAIMS THAT AFTER ASPIRATING WITH THE NEEDLE 16G X 3 FOUR TIMES THE NEEDLE DETACHED FROM THE LUER LOCK AND CAUSED PATIENT A PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY THORACENTESIS 16GAX3 TRAY THORACENTESIS 16GAX3 GCB CAREFUSION 4340A NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR