BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT CHECK QUALITY CONTROL

    MDR report key: 1931927 · Received November 30, 2010

    Report

    Report Number
    2250033-2010-00019
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2010. REFERENCES ITC COMPLAINT # (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: COMPLAINT VERIFIED. DEVICE FAILURE MAY HAVE CONTRIBUTED TO ALLEGED EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A SHARD OF GLASS PIERCED THE CONTROL TUBE AND CUT HER FINGER WHILE CRUSHING THE DIRECTCHECK CONTROL. CUSTOMER REPORTS SHE WAS USING THE PROTECTIVE SLEEVE PROVIDED. THE PROTECTIVE SLEEVE IS PROVIDED FOR USE WHEN CONTROL VIALS ARE ACTIVATED. NO REPORT OF SERIOUS INJURY, OR MEDICAL TREATMENT ADMINISTERED.

    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 D0DNL017

    Patients

    Seq Age Sex Outcome Treatment
    1