BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6981016 · Received October 26, 2017

    Report

    Report Number
    1625685-2017-00412
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    August 10, 2017
    Report Date
    November 27, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    KNW
    PMA / PMN Number
    K003370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO COMPLAINT SAMPLE WAS PROVIDED FOR EVALUATION AND NO LOT NUMBER WAS REPORTED, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY ANY PROBABLE ROOT CAUSE. THE INVESTIGATION DID NOTED A PREVIOUS CAPA INVESTIGATION THAT WAS INITIATED DUE TO OPEN SEAL COMPLAINTS IN THE SAME PRODUCT FAMILY. THIS COMPLAINT INVESTIGATION WAS NOT ABLE TO DETERMINE IF THE CORRECTIVE ACTIONS FROM THE IDENTIFIED CAPA WERE APPLICABLE TO THIS COMPLAINT SINCE A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION COULD NOT ASSESS IF THE PRODUCT IN QUESTION WAS PRODUCED PRIOR TO OR AFTER THE IMPLEMENTATION OF THE CORRECTIVE ACTION FROM THE CAPA. SINCE ROOT CAUSE CANNOT BE DETERMINED, NO CORRECTIVE ACTIONS WILL BE IMPLEMENTED AT THIS TIME. WE WILL, HOWEVER, TRACK AND TREND FUTURE COMPLAINTS TO SEE IF THIS ISSUE RECURS. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4) . INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON A NEW NEEDLE BOX FROM JAMSHIDI CAT TJM4008, PEREMPTION 31/08/2020, OPENED THIS MORNING, WE FOUND 3 PACKETS, NORMALLY STERILE, WHICH WERE NOT WELDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761997 JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC INSTRUMENT, BIOPSY KNW BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other