BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLISENS EASYMAG EXTRACTION BUFFER 1

    MDR report key: 1982485 · Received February 9, 2011

    Report

    Report Number
    1950204-2011-00001
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A SMALL AMOUNT OF EXTRACTION BUFFER 1 SOLUTION WAS PROJECTED INTO THE EYES OF THE OPERATOR DURING REMOVAL OF THE CONNECTORS FROM THE REAGENT BOTTLES. THE OPERATOR RINSED WITH WATER AND RECEIVED MEDICINE FROM THE DOCTOR. THE DOCTOR DETERMINED THERE WAS NO DAMAGE TO THE OPERATOR'S EYE. NO FURTHER INFORMATION WAS COMMUNICATED DUE TO PRIVACY REASONS. THE COMPLAINT EVALUATION CONCLUDED THAT THE OPERATOR WAS NOT WEARING SAFETY GLASSES AS RECOMMENDED IN THE EASYMAG INSTRUMENT INSTRUCTION MANUAL AND IN THE EXTRACTION BUFFER 1 INSTRUCTION FOR USE. THE EASYMAG USER MANUAL INSTRUCTS OPERATORS; "WHEN REMOVING CONNECTORS FROM REAGENT BOTTLES, HOLD THE CONNECTOR IN PLACE WHILE PRESSING THE RELEASE BUTTON, AND ALLOW THE CONNECTOR TO RELEASE SLOWLY. IF THE CONNECTOR IS RELEASED SUDDENLY, IT MAY BE POSSIBLE FOR SOME REAGENT TO FLICK OFF. WEAR SAFETY GLASSES WHILE CARRYING OUT THIS PROCEDURE." THIS COMPLAINT IS AN ISOLATED EVENT THAT IS NOT RELATED TO A MALFUNCTION OF THE PRODUCT. THIS IS THE FINAL MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLISENS EASYMAG EXTRACTION BUFFER 1 REAGENT, GENERAL PURPOSE LDT BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention