BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI (TJ) NEEDLE BONE MARROW 11GX4

    MDR report key: 1812133 · Received August 9, 2010

    Report

    Report Number
    1625685-2010-00025
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    June 24, 2010
    Report Date
    August 6, 2010
    Manufacturer
    CAREFUSION
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION; THEREFORE, THE QUALITY OF THE BIOPSY NEEDLE ASSEMBLY COULD NOT BE EVALUATED IN REGARDS TO THE ISSUE REPORTED. A REVIEW OF COMPLAINT DATA DID NOT IDENTIFY ANY TREND WITH THIS OR SIMILAR FAILURE MODES. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES IDENTIFIED A SPECIFIC MANUFACTURING STEP FOR THE GRINDING OF THE STYLET TIP OF THE BIOPSY NEEDLE ASSEMBLY. A DEVICE HISTORY REVIEW (DHR), RAW MATERIAL HISTORY FILES AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT SHOWED ONE NON-CONFORMANCE. PRODUCT WAS 100% CULLED AND QUALITY RELEASED. THERE WERE NO OTHER RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ALL APPLICABLE MANUFACTURING AND QUALITY PERSONNEL WILL BE NOTIFIED OF THIS FAILURE MODE IN AN EFFORT TO HEIGHTEN AWARENESS AND MINIMIZE IMPACT FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    DURING A MARROW PROCEDURE, THE USER HAD TO PROCEED 3 TIMES TO GET THE SAMPLE. THE FIRST 2 TROCARS BECAME BENT (ANGLED) THROUGH PRESSURE NEEDED FOR THE ENTRANCE TO GET THE BIOPSY SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI (TJ) NEEDLE BONE MARROW 11GX4 JAMSHIDI (TJ) NEEDLE BONE MARROW 11GX4 KNW CAREFUSION TJC4011 L8P305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other