BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP

    MDR report key: 7990509 · Received October 22, 2018

    Report

    Report Number
    9680904-2018-00023
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 1, 2018
    Report Date
    November 8, 2018
    Manufacturer
    CAREFUSION, INC
    Product Code
    JAM
    PMA / PMN Number
    K813338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PR 589627 OUR MANUFACTURING QUALITY ENGINEER RECEIVED EIGHT PHOTOS (8) FOR EVALUATION. IT COULD BE SEEN THAT THE POUCHES ARE OPEN ON THE SIDES, THEREFORE, FAILURE MODE COULD BE CONFIRMED. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED FOR THE REPORTED LOT NUMBERS MANUFACTURED CONFIRMING PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEED FOR THE PRODUCT TO BE RELEASED WERE MET. ALTHOUGH REPORTED FAILURE WAS CONFIRMED THROUGH VISUAL ANALYSIS A ROOT CAUSE COULD NOT BE DETERMINED THROUGH THIS INVESTIGATION. AS A RESULT A CAPA HAS BEEN INITIATED.

    Description of Event or Problem · 0

    THE SEAL IS OPEN PARTIALLY ON THE PRODUCT POUCH.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP SUBMISSION WILL BE COMPLETED POST INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SEAL IS OPEN PARTIALLY ON THE PRODUCT POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829320 JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP BIOPSY NEEDLES & TRAYS JAM CAREFUSION, INC 0001240515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other