BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS CHEMISTRY PRODUCTS SPECIALTY DILUENT

    MDR report key: 1891714 · Received November 5, 2010

    Report

    Report Number
    1319808-2010-00019
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    September 25, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    GIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING STATEMENT APPEARS IN THE INSTRUCTIONS FOR USE FOR VITROS CHEMISTRY PRODUCTS SPECIALTY DILUENT: "HANDLE AS IF CAPABLE OF TRANSMITTING DISEASE. THIS PRODUCT IS PREPARED FROM HUMAN SERUM. EACH DONOR UNIT USED IN PREPARATION OF THE PRODUCT WAS (B)(6) USING FDA APPROVED METHODS. HOWEVER, SINCE NO TEST CAN OFFER COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT, THIS PRODUCT SHOULD BE HANDLED FOLLOWING THE RECOMMENDATIONS MADE IN CLSI GUIDELINE M29, OR OTHER PUBLISHED BIOHAZARD SAFETY GUIDELINES." PERSONAL PROTECTIVE EQUIPMENT (SAFETY GLASSES) WAS BEING WORN AT THE TIME OF THE EVENT, HOWEVER, FLUID STILL SPLASHED INTO THE CUSTOMER'S EYE. THE CUSTOMER FLUSHED THE AFFECTED EYE WITH WATER.

    Description of Event or Problem · 1

    A CUSTOMER SPLASHED VITROS CHEMISTRY PRODUCTS SPECIALTY DILUENT INTO THEIR EYE. THE FLUID CONTAINS HUMAN BLOOD PRODUCTS. THERE WAS NO IMMEDIATE HARM TO THE CUSTOMER AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS SPECIALTY DILUENT IN-VITRO DIAGNOSTIC DILUENT GIF ORTHO-CLINICAL DIAGNOSTICS P9443

    Patients

    Seq Age Sex Outcome Treatment
    1