BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 1633700 · Received March 3, 2010

    Report

    Report Number
    2250033-2010-00005
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 3, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER METHOD: MANUFACTURER UNABLE TO PERFORM EVALUATION AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM USER FACILITY AND USER FACILITY UNABLE TO PROVIDE LOT NUMBER OF QUALITY CONTROL PRODUCT INVOLVED. RESULTS: MANUFACTURER UNABLE TO PERFORM EVALUATION AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM USER FACILITY AND USER FACILITY UNABLE TO PROVIDE LOT NUMBER OF QUALITY CONTROL PRODUCT INVOLVED. CONCLUSIONS: MANUFACTURER UNABLE TO PERFORM EVALUATION AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM USER FACILITY AND USER FACILITY UNABLE TO PROVIDE LOT NUMBER OF QUALITY CONTROL PRODUCT INVOLVED. USER ERROR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BEING CUT BY THE AMPULE WHILE CRUSHING THE DIRECT CHECK CONTROL VIAL. CUSTOMER REMOVED THE PROTECTIVE SLEEVE, PROVIDED FOR USE WHEN CONTROL VIALS ARE ACTIVATED, AND CUT HERSELF. NO REPORT OF SERIOUS INJURY, OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT CHECK QUALITY CONTROL DIRECT CHECK NORMAL ACT-LR GGN INTERNATIONAL TECHNIDYNE CORP. DCJLR-A F9DLA033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other