BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM CVP (CALIBRATION VALUATION PRODUCT)1 WITH CO-OX

    MDR report key: 7415356 · Received April 10, 2018

    Report

    Report Number
    1217183-2018-00003
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 16, 2018
    Report Date
    April 9, 2018
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    JJY
    UDI-DI
    08426950440680
    PMA / PMN Number
    K112995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED THAT THEIR FINGER WAS CUT WHEN THEY SNAPPED OPEN A VIAL OF GEM CVP1 WITH CO-OX. THE CUT WAS MINOR; THE WOUND WAS WASHED AND DRESSED. AN INSTRUMENTATION LABORATORY (IL) REPRESENTATIVE CONTACTED THE FACILITY. THE FACILITY VERIFIED THAT PROTOCOL WAS NOT FOLLOWED; THE OPERATOR SHOULD HAVE USED THE AMPOULE BREAKER. INSTRUMENTATION LABORATORY'S REVIEW OF THE OPERATOR'S MANUAL AND INSTRUCTION FOR USE SHEET CONFIRMED APPROPRIATE INSTRUCTION FOR THE USE OF THE AMPOULE BREAKER TO SNAP OPEN THE AMPOULE. NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER CUT THEIR FINGER WHILE SNAPPING OPEN A CVP VIAL. THE CUSTOMER REPORTED THAT IT WAS A MINOR CUT. HE REMOVED GLOVES TO WASH HANDS WITH SOAP AND WATER, THEN USED A BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259297 GEM CVP (CALIBRATION VALUATION PRODUCT)1 WITH CO-OX BLOOD GAS QUALITY CONTROL SOLUTION JJY INSTRUMENTATION LABORATORY 08426950440680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other