BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC BONE NEEDLE

    MDR report key: 1646499 · Received March 23, 2010

    Report

    Report Number
    1036710-2010-00012
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K980196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEDIATRIC BONE NEEDLE WAS USED IN A (B)(6) PT. THERE WERE FIVE DEVICE SAMPLES FROM THE LOT INVOLVED IN STOCK WHEN THE EVENT WAS REPORTED. THESE SAMPLES WERE PULL TESTED WITH ACCEPTABLE RESULTS. THE DEVICE SAMPLE USED WAS RETURNED AND INVESTIGATED. FROM REVIEWING THE SAMPLE, IT WAS NOTED THE CANNULA PULLED FROM THE HUB INTACT; IT DID NOT BREAK OFF. THE CUSTOMER ALSO RETURNED FOUR ADD'L DEVICES FROM THE LOT NUMBER, WHICH WERE ALSO PULL TESTED WITH ACCEPTABLE RESULTS. THE INSERTION SITES RECOMMENDED IN THE DFU FOR THIS NEEDLE IS THE TIBIAL TUBEROSITY OR THE MEDIAL MALLEOLUS OF THE DISTAL TIBIA. THE NEEDLE WAS USED IN THE ILIUM WHICH IS KNOWN TO BE MORE DENSE THEN THE RECOMMENDED INSERTION SITES. THE REPORTER STATED THE DOCTOR DID NOT MOVE THE DEVICE RIGHT AND LEFT; INSTEAD THE DOCTOR PULLED WITH STRENGTH WHEN RESISTANCE WAS FELT AND THE NEEDLE COULD NOT BE REMOVED EASILY. THE CANNULA IS DESIGNED TO BE ROTATED BACK AND FORTH AND WORKS OPTIMALLY WHEN USING THIS MOTION RATHER THAN PULLING THE NEEDLE STRAIGHT OUT. THE DFU INCLUDED WITH THE PRODUCT STATES: "TO REMOVE THE NEEDLE, APPLY GENTLE TRACTION AND ROTATE THE NEEDLE CANNULA BACK AND FORTH TO DISENGAGE FROM BONE CORTEX." THIS STATEMENT IS INCLUDED THE DFU SINCE IT REDUCES THE FORCE REQUIRED TO REMOVE THE NEEDLE AS IT MAKES THE HOLE CREATED BIGGER AND THUS REDUCES THE FRICTION.

    Description of Event or Problem · 1

    WE RECEIVED THE REPORT FROM OUR DISTRIBUTOR. THEY STATED: THE CANNULA FELL OUT FROM THE HUB AND REMAINED IN THE PT. THE CUSTOMER CONDUCTED A BONE MARROW BIOPSY APPROACHING FROM ILIUM (ASPIRATED ONLY ONCE). THEY ASPIRATED IN STRAIGHT LINE, EXTRACT BONE MARROW AND PULLED BACK THE PRODUCT WITHOUT BENDING (WITHOUT STYLET REPOSITION). RESISTANCE WAS FELT AND COULD NOT TAKE THE NEEDLE OUT EASILY. WHEN PULLED WITH STRENGTH, ONLY THE HUB FELL OUT AND THE CANNULA REMAINED IN THE PT. THE DOCTOR DID NOT MOVE THE NEEDLE RIGHT AND LEFT. ADD'L INFO: FROM DR: BONE MARROW OVER SPILLED FROM THE REMAINING NEEDLE. TOOK APPROX 15 MINUTES TO STOP BLEEDING AFTER TAKING OUT THE REMAINING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC BONE NEEDLE PEDIATRIC BONE MARROW NEEDLE KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES ION18015 90761T8O

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R