BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2119510 · Received June 10, 2011

    Report

    Report Number
    1319681-2011-00129
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    September 25, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VITROS 3600 SYSTEM DEVICE LABELING INCLUDES THE FOLLOWING: "ASSUME THAT ALL USED EQUIPMENT IS CONTAMINATED WITH POTENTIALLY INFECTIOUS BIOLOGICAL MATERIAL. NOTE: IN THE UNITED STATES, USE THE "UNIVERSAL PRECAUTIONS" RECOMMENDED BY OSHA (OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION) BLOODBORNE PATHOGEN STANDARD 29CFR1910.1030 WHEN HANDLING, CLEANING, AND PACKING EQUIPMENT. IN PARTICULAR: - WEAR GLOVES, CLOSED SHOES, BUTTONED LAB COATS, AND SAFETY GLASSES THROUGHOUT THE CLEANING AND MAINTENANCE PROCESS. - TREAT ALL WASTE MATERIALS USED IN THE CLEANING PROCESS AS CONTAMINATED. FOLLOW THE SITE PROCEDURES FOR YOUR LABORATORY TO DISPOSE OF THESE MATERIALS. BLOODBORNE PATHOGENS. OBSERVE UNIVERSAL PRECAUTIONS FOLLOWING THE OSHA BLOODBORNE PATHOGENS STANDARD AND THE (B)(4) GUIDELINES AT ALL TIMES WHEN DEALING WITH BLOOD OR BODY FLUID AND CONTAMINATED EQUIPMENT." PERSONAL PROTECTIVE EQUIPMENT (GLOVES AND LAB COAT) WERE BEING WORN AT THE TIME OF THE EVENT, HOWEVER, FLUID SPLASHED ON THE FACE OF THE OPERATOR, POSSIBLY COMING INTO CONTACT WITH MUCUS MEMBRANES. THE OPERATOR FLUSHED THE AFFECTED AREA WITH WATER. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SPLASHED PATIENT SAMPLE FLUIDS IN THEIR EYE WHILE PERFORMING MAINTENANCE TO THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THIS EVENT CONSTITUTES POTENTIAL BIOHAZARD EXPOSURE, AS THERE IS NOT COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1