BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, BIOPSY, 8GAX4", JAMSHIDI

    MDR report key: 1031996 · Received April 21, 2008

    Report

    Report Number
    1423507-2008-00035
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    December 12, 2007
    Report Date
    April 21, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO SAMPLE WAS RECEIVED FOR EVALUATION; THEREFORE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD, RAW MATERIAL HISTORY FILES AND THE STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOTS SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS REPORTED INCIDENT. A REVIEW OF ALL MFG PROCESSES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THIS FAILURE MODE. THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE AND THEREFORE A ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    DURING SAMPLE RETRIEVAL DURING A BONE MARROW BIOPSY, THE TROCAR BROKE AT THE REMOVAL STAGE. NEEDLE TIP STILL IN THE PATIENT'S BONE. THE PROCEDURE COULD NOT BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE, BIOPSY, 8GAX4", JAMSHIDI NEEDLE, BIOPSY, 8GAX4", JAMSHIDI KNW CARDINAL HEALTH CJ4008X L3A133

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR