BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC - TJM4008

    MDR report key: 14454423 · Received May 20, 2022

    Report

    Report Number
    1625685-2022-00056
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 5, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    KNW
    UDI-DI
    10885403044564
    PMA / PMN Number
    K913306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: (B)(4). PATIENT PROBLEM CODE: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO AND ONE SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED A SLIVER APPROXIMATELY 3 QUARTERS OF AN INCH IN LENGTH WITH A WIDTH APPROXIMATELY THE SAME AS A PENCIL LEAD. THE SMALL SLIVER WAS EXAMINED UNDER MAGNIFICATION. THE PHYSICAL CHARACTERISTICS OF THE ITEM INDICATED IT WAS PARTIALLY METAL OF 2 OR MORE COLORS AND MAGNETIC. THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURE NARRATION.

    Description of Event or Problem · 0

    IRON FILINGS FOUND IN THE TROCAR (SEALED IN THE BAG FOR VISUALIZATION) TO OUR KNOWLEDGE, THE PATIENT WAS NOT INVOLVED.

    Description of Event or Problem · 0

    IRON FILINGS FOUND IN THE TROCAR (SEALED IN THE BAG FOR VISUALIZATION). TO OUR KNOWLEDGE, THE PATIENT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001235 JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC - TJM4008 INSTRUMENT, BIOPSY KNW CAREFUSION, INC TJM4008 UNKNOWN 10885403044564

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other