BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 1931906 · Received November 30, 2010

    Report

    Report Number
    2250033-2010-00018
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD: DEVICE HISTORY RECORD, NCMR, CAPA AND COMPLAINT HISTORY EVALUATED. NO PRODUCT RETURNED. RESULTS: RECORD EVALUATION COMPLETED. PRODUCT MET ALL RELEASE CRITERIA. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. USER ERROR MAY HAVE CONTRIBUTED TO ALLEGED EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A SHARD OF THE GLASS AMPOULE PIERCED THE PLASTIC TUBE AND HER FINGER WHILE CRUSHING THE DIRECTCHECK CONTROL. CUSTOMER REPORTS THE PROTECTIVE SLEEVE PROVIDED WAS NOT USED WHEN THE AMPOULE WAS CRUSHED. THE PROTECTIVE SLEEVE IS PROVIDED FOR USE WHEN CONTROL VIALS ARE ACTIVATED. 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 PROTIME LEVEL 2 GGN INTERNATIONAL TECHNIDYNE CORP. DCPRO-A B0DAP002

    Patients

    Seq Age Sex Outcome Treatment
    1