BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITC WHOLE BLOOD CONTROL

    MDR report key: 3993985 · Received July 24, 2014

    Report

    Report Number
    2250033-2014-00032
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON (B)(4) 2014 REFERENCES ITC COMPLAINT CASE (B)(4). NO NCMRS IDENTIFIED. NO RELATED COMPLAINT TRENDS OR CAPAS IDENTIFIED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTS END USER INJURY WHILE PREPARING THE ITC WHOLE BLOOD CONTROL. HEALTH PROFESSIONAL WAS ADDING DILUENT WITH A SYRINGE TO RECONSTITUTE THE DRIED WHOLE BLOOD CONTROL MATERIAL. WHEN WITHDRAWING THE NEEDLE FROM THE VIAL, HEALTH PROFESSIONAL PUNCTURED HER LATERAL PALM OF LEFT HAND WITH SYRINGE. HEALTH PROFESSIONAL WAS WEARING GLOVES AT THIS TIME. THE WOUND WAS CLEANSED WITH AN ANTIBACTERIAL SCRUB. ITC WHOLE BLOOD CONTROL DOES NOT CONTAIN HUMAN BLOOD PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435164 ITC WHOLE BLOOD CONTROL PLASMA, COAGULATION CONTROL GGN INTERNATIONAL TECHNIDYNE CORP. QCACT C4TCA007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other