BEUDAMED
    FDA Adverse Event Other Summary report: N

    BONE MARROW BIOPSY NEEDLE.

    MDR report key: 553788 · Received November 5, 2004

    Report

    Report Number
    1423507-2004-00113
    Event Type
    Other
    Date Received
    November 5, 2004
    Date of Event
    September 2, 2004
    Report Date
    November 5, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CANNULA BROKE AND LEFT APPROX 1CM OF DEVICE INSIDE THE BONE DURING BONE BIOPSY PROCEDURE. IN PROCESS OF OBTAINING INFORMATION FROM THE HOSPITAL REGARDING THE INCIDENT ITSELF TO CONFIRM IF AN "INJURY" OCCURRED, SO HAVE TO REPORT THIS INCIDENT AT PRESENT AS "NO INJURY". ALSO, THE SAMPLE IS PRESENTLY IN PROCESS OF BEING STERILIZED. ADDITIONALLY CUSTOMER STATED 2004, THE PROCEDURE WAS ABORTED WHEN THE DEVICE BROKE AND THE BROKEN PIECE OF CANNULA COULD NOT BE RETRIEVED. TWO DAYS LATER BROKEN PIECE OF CANNULA WAS RETRIEVED DURING A SECOND OPERATION. THE HOSPITAL REPORTED THAT DOCTORS HAD CONSIDERED PERFORMING A RADIOFREQUENCY TO REMOVE THE BROKEN PIECE OF CANNULA, BUT DECIDED AGAINST IT AND INSTEAD PERFORMED THIS SECOND SURGICAL OPERATION. INITIALLY THE USED SAMPLE HAD BEEN AVAILABLE FOR INVESTIGATION, HOWEVER THE SAMPLE CAN NO LONGER BE STERILIZED FOR THE INVESTIGATION, AND AS SUCH, A SAMPLE WILL NO LONGER BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MARROW BIOPSY NEEDLE. NEEDLE FCG CARDINAL HEALTH BT257 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other