BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 1900229 · Received October 25, 2010

    Report

    Report Number
    2250033-2010-00016
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR METHOD - NO PRODUCT RETURNED FROM USER FACILITY. MFR RESULTS - CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. MFR CONCLUSIONS - NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT WHILE CRUSHING A DIRECT CHECK VIAL, THE END USER RIGHT INDEX FINGER WAS PUNCTURED IN TWO PLACES. CUSTOMER STATED THAT GLOVES AND THE PROTECTIVE SLEEVES THAT COMES WITH THE CONTROL VIAL WERE USED AT THE TIME OF THE INCIDENT AND CONTROL SAMPLE PENETRATED THE SKIN IN BOTH PUNCTURED AREAS.

    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-N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other