BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAMSHIDI NEEDLE BONE MARROW 11GX6 ASP

    MDR report key: 1902453 · Received October 15, 2010

    Report

    Report Number
    9680904-2010-00017
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RECEIVED FOR EVALUATION AND DURING VISUAL INSPECTION IT WAS FOUND THAT THE METAL HUB OF THE CANNULA WAS SEPARATED FROM THE CANNULA. THEREFORE; WE ARE ABLE TO CONFIRM THE ISSUE REPORTED. THE CAUSE FOR THE ISSUE REPORTED IS DUE TO THE BOND PULL TEST FOR THE HUB CANNULA JUNCTION. THE TEST WAS NOT BEING PERFORMED CORRECTLY AND THEREFORE, THE RESULTS WERE THAT THE UNIT OF MEASURE WERE NOT CONSISTENT. AS CORRECTIVE ACTION, THE PROCEDURE FOR THE BOND PULL TEST HAS BEN MODIFIED AND RETRAINING OF THE PERSONNEL WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REPORTED FOUND ISSUES RELATED TO THIS FAILURE MODE DURING THE DOCUMENTATION REVIEW.

    Description of Event or Problem · 1

    THE HANDLE OF THE NEEDLE BROKE OFF WHILE INSIDE PATIENT. DOCTOR NEEDED TO USE PLIERS TO REMOVE BROKEN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI NEEDLE BONE MARROW 11GX6 ASP TRAY, SURGICAL, NEEDLE/FSH FSH CAREFUSION DJ6011X D09030418

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other