BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI (TJ) NEEDLE BM 8GX4 ASP MAC

    MDR report key: 1964261 · Received January 19, 2011

    Report

    Report Number
    1625685-2011-00004
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 19, 2011
    Manufacturer
    CAREFUSION
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE COMPLAINT SAMPLE CONFIRMED THE NEEDLE WAS FRACTURED. INSPECTION OF THE FRACTURED COMPONENT SUGGESTED THE NEEDLE WAS BENT DUE TO EXCESSIVE FORCE; HOWEVER THIS FAILURE MODE COULD NOT BE DEFINITIVELY CONFIRMED BY THE COMPLAINT INVESTIGATION. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TRENDS WITH THIS OR SIMILAR FAILURE MODES. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILE AND STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ALL APPLICABLE QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS REGARDING THIS DEFECT. (B)(4)

    Description of Event or Problem · 1

    MARROW ACQUISITION CRADLE BROKE INSIDE CANNULA WHILE TRYING TO ABSTRACT BONE MARROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI (TJ) NEEDLE BM 8GX4 ASP MAC JAMSHIDI (TJ) NEEDLE BM 8GX4 ASP MAC KNW CAREFUSION TJM4008 L0P140

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other