BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI

    MDR report key: 1580417 · Received January 7, 2010

    Report

    Report Number
    1580417
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    December 2, 2009
    Report Date
    January 7, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO PULL BIOPSY NEEDLE OUT AFTER BONE CORE SAMPLES WERE TAKEN AND THE BIOPSY NEEDLE BROKE OFF. A FRAGMENT OF THE NEEDLE WAS LEFT IN THE PATIENT. BOTH PHYSICIANS CONSULTED AND CAME TO AGREEMENT TO LEAVE THE NEEDLE. THE PARENTS OF THE PATIENT WERE NOTIFIED.MANUFACTURER RESPONSE (AS PER REPORTER) FOR BONE MARROW ASPIRATION NEEDLE, JAMSHIDI:SHE WILL COME IN AND LOOK AT THE BROKEN DEVICE, MAYBE TAKE PHOTOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI BONE MARROW ASPIRATION NEEDLE LWE CARDINAL HEALTH * L9J293

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR