BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING ARRAY INSERTION TUBE W/STYLET

    MDR report key: 1232742 · Received November 14, 2008

    Report

    Report Number
    3005677147-2008-00012
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 2008
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K003776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO FHC FOR EVALUATION, WHICH REVEALED INSUFFICIENT ADHESIVE ON THE TUBES. DUE TO THE POTENTIAL FOR PT INJURY FROM THIS ERROR, A CORRECTIVE CUSTOMER COMMUNICATION WILL BE SENT TO ALL MICROTARGETING DRIVE USERS WITH INSTRUCTIONS FOR A PRE-USE CHECK OF THE TUBES. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE CORRECTION AND REMOVAL REPORTING NUMBER, WHEN ASSIGNED.

    Description of Event or Problem · 1

    DISTRIBUTOR SALES REPRESENTATIVE REPORTED AN INCIDENT WHERE "AT INSERTING THE INSERTION CANNULA, THE DOCTOR NOTICED THAT THE MANDRIN IN THIS CANNULA SUDDENLY WAS PUSHED INSIDE THE LUMEN OF INSERTION CANNULA. AFTER ANALYSIS OF THE INSERTION CANNULA IT WAS CONCLUDED THAT THE "INNERTUBE" OF THE INSERTION CANNULA COULD MOVE IN THE OUTER TUBE OF THE INSERTION CANNULA. AS A RESULT THE MANDRIN "DISAPPEARED" INSIDE THE THICKER PART OF THE INSERTION CANNULA. IT COULD NOT BE VERIFIED HOW MUCH THE INNER TUBE OF THE INSERTION CANNULA WAS DEEPER THAN INTENDED. THE PROBLEM WAS CORRECTED AND THE CANNULA WAS USED AS SUCH; NO SPARE CANNULA AVAILABLE." THERE WAS NO PT IMPACT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ARRAY INSERTION TUBE W/STYLET HAW FHC, INC. FC1018 6370930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other