BEUDAMED
    FDA Adverse Event Other Summary report: N

    BONE MARROW TRAY

    MDR report key: 2483132 · Received March 5, 2012

    Report

    Report Number
    1036710-2012-00002
    Event Type
    Other
    Date Received
    March 5, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ANGIOTECH MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K980196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLE WAS RETURNED FOR REVIEW AND THE DEFECT REPORTED WAS CONFIRMED. THE CANNULA OF THE EXTRACTION CANNULA IS LONGER THEN INTENDED. THE NEEDLE HAS ALSO BEEN REVIEWED BY THE SUPPLIER. THE CANNULA WAS MOLDED INCORRECTLY. DUE TO THE NATURE OF THE SURGERY THE INCORRECT LENGTH OF THE CANNULA WOULD NOT CAUSE PT HARM AS THE CANNULA IS THINNER THAN THE BONE NEEDLE ALREADY INSERTED. IT COULD CAUSE BLOOD CONTACT WITH THE DR IF THE CANNULA GATHERS A LARGER SAMPLE THAN DESIRED AND THE DR IS NOT WEARING STANDARD PROTECTION. THIS IS THE FIRST REPORT FOR THIS DEFECT AND IS CONSIDERED AN ISOLATED EVENT. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    MD STATES THAT THE EXTRACTION CANNULA WAS LONGER THAN THE T LOK NEEDLE; TYPICALLY THE EXTRACTION CANNULA SHOULD BE FLUSH WITH THE NEEDLE. DURING A PROCEDURE USING THE T LOK BONE MARROW TRAY, BLOOD EXITED OUT OF THE NEEDLE AND THE PHYSICIAN'S FACE WAS EXPOSED TO THE FLUIDS. MD STATES THAT THIS IS DUE TO THE EXTRA LENGTH OF THE EXTRACTION CANNULA. EXPOSURE TO BODILY FLUIDS MAY POTENTIALLY BE HARMFUL TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MARROW TRAY T LOK BONE MARROW TRAY KNW ANGIOTECH MEDICAL DEVICE TECHNOLOGIES BMET1104ATL 120927UZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other