BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLINOIS NEEDLE BONE MARROW

    MDR report key: 7277593 · Received February 16, 2018

    Report

    Report Number
    9680904-2018-00002
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 22, 2018
    Manufacturer
    CAREFUSION, INC
    Product Code
    FSH
    PMA / PMN Number
    K813338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) OUR QUALITY ENGINEERS RECEIVED ONE PHOTO FROM LOT #0000919888 FOR EVALUATION. FAILURE MODE COULD BE CONFIRMED SINCE THE MANUFACTURING DATE PRINTED WAS INCORRECT ACCORDING TO PRODUCT CODE/BATCH. THE INVESTIGATION CONCLUDED THE ROOT CAUSE COULD BE RELATED TO THE MANUFACTURING PROCESS AND METHODS. WE HAVE SINCE OPENED UP A CAPA AND DURING THE SAMPLING REVIEW PROCESS, BD VERIFIED THE EXPIRATION AND MANUFACTURING DATE ON LABELS WERE ACCURATE. THE FAILURE MODE WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED / TRENDED FOR ANY ADDITIONAL SIMILAR FAILURE MODES. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS DURING OUR QUALITY TEAM MEETING. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP EMDR SUBMISSION WILL BE COMPLETED UPON COMPLETION OF INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    LABELING ABNORMALITY ON 11 NEEDLES FOR STERNAL PUNCTURE OF THE SAME LOT. THE STATED EXPIRY DATE IS 27/02/2021 AND THE MANUFACTURING DATE OF 30/03/2030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122578 ILLINOIS NEEDLE BONE MARROW BIOPSY NEEDLES & TRAYS FSH CAREFUSION, INC 0000919888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other