BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC

    MDR report key: 1646651 · Received March 25, 2010

    Report

    Report Number
    1625685-2010-00007
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    January 12, 2010
    Report Date
    March 23, 2010
    Manufacturer
    CAREFUSION
    Product Code
    LWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVAL; THEREFORE, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE ISSUE REPORTED. A LOT NUMBER WAS NOT REPORTED; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IMPROVEMENTS TO THIS PRODUCT HAVE BEEN MADE TO THE MFG PROCESS OF THE BIOPSY NEEDLE TO MINIMIZE THE REOCCURRENCE OF THE SUPER RETENTION FAILURE MODE. THESE IMPROVEMENTS INCLUDED A NARROWING OF CERTAIN MFG SPECIFICATIONS WITH REGARDS TO THE GRINDING AND FORMING OPERATION OF THE NEEDLE. SINCE A LOT NUMBER WAS NOT PROVIDED, WE ARE UNABLE TO DETERMINE IF THIS DEVICE WAS PRODUCED WITH THESE PRODUCT IMPROVEMENTS. A REVIEW OF APPLICABLE MFG PROCEDURES DID NOT IDENTIFY ANY ISSUES WITH THE CURRENT MFG PROCESS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE.

    Description of Event or Problem · 1

    CUSTOMER STATED, "THE ONCOLOGIST HEMATOLOGIST STATES THAT IT IS DIFFICULT TO RELEASE THE BONE MARROW AFTER SHE HAS EXTRACTED IT FROM THE BONE MARROW. IN ONE BONE MARROW PROCEDURE, THE DOCTOR STUCK HERSELF WITH THE NEEDLE ATTEMPTING TO GET THE BONE MARROW OUT FOR THE LAB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC LWE CAREFUSION BCTM3411 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other