BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1917008 · Received December 8, 2010

    Report

    Report Number
    1319681-2010-00266
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    September 25, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VITROS 5,1 FS CHEMISTRY SYSTEM DEVICE LABELING STATES THE FOLLOWING: "PRECAUTIONS: ASSUME THAT ALL USED EQUIPMENT IS CONTAMINATED WITH POTENTIALLY INFECTIOUS BIOLOGICAL MATERIAL. NOTE: IN THE UNITED STATES, (B)(4) RECOMMEND UNIVERSAL PRECAUTIONS DESCRIBED IN THE BLOODBORNE PATHOGEN STANDARD 29CFR1910.1030 WHEN HANDLING, CLEANING, AND PACKING THE EQUIPMENT. WEAR GLOVES, CLOSED SHOES, BUTTONED LAB COATS, AND SAFETY GLASSES THROUGHOUT THE CLEANING AND MAINTENANCE PROCESS (AND PACKING, IF THE SYSTEM IS BEING SHIPPED OR RELOCATED). HANDLE ALL EQUIPMENT WITH CARE. MECHANICAL PARTS MAY HAVE EDGES, PINCH POINTS, AND CORNERS THAT POTENTIALLY COULD CAUSE INJURY. TREAT MATERIALS USED IN THE CLEANING PROCESS AS CONTAMINATED. FOLLOW THE SITE PROCEDURES FOR YOUR LABORATORY TO DISPOSE OF THESE MATERIALS. OUTSIDE THE UNITED STATES, FOLLOW WHO (B)(4) AND YOUR COUNTRY'S REGULATIONS FOR HANDLING AND CLEANING BLOODBORNE PATHOGENS. BLOODBORNE PATHOGENS. OBSERVE UNIVERSAL PRECAUTIONS FOLLOWING THE (B)(4) BLOODBORNE PATHOGENS STANDARD AND THE (B)(4) AND (B)(4) GUIDELINES AT ALL TIMES WHEN DEALING WITH BLOOD OR BODY FLUID AND CONTAMINATED EQUIPMENT." PERSONAL PROTECTIVE EQUIPMENT (SAFETY GLASSES) WERE NOT BEING WORN AT THE TIME OF THE EVENT. THE OPERATOR FLUSHED THE AFFECTED EYE WITH WATER. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN OPERATOR SPLASHED PATIENT SERUM IN THEIR EYE WHILE CLEANING THE SECONDARY TIP SEALER ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THIS EVENT CONSTITUTES BIOHAZARD EXPOSURE. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1