BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3250481 · Received July 26, 2013

    Report

    Report Number
    1319681-2013-00144
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT A LIQUID WASTE WAS SPLASHED ONTO THE CUSTOMER¿S FACE WHILE THE INDIVIDUAL WAS ATTEMPTING TO REPLACE THE LIQUID WASTE QUICK DISCONNECT CAP ON THE VITROS 5600 ANALYZER. THE INCIDENT WAS UNLIKELY TO HAVE INVOLVED EXPOSURE OF A MUCOSAL MEMBRANE TO THE WASTE HOWEVER THIS COULD NOT BE RULED OUT. THE CUSTOMER CLEANED THE EXPOSED SKIN AREAS AND DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OPERATOR ERROR COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER WAS SPLASHED IN THE CHEEK AND NECK AREA WITH LIQUID WASTE WHILE ATTEMPTING TO REPLACE THE LIQUID WASTE QUICK DISCONNECT CAP ON THE VITROS 5600 SYSTEM. THIS EVENT CONSTITUTES BIOHAZARD EXPOSURE. THERE WAS NO IMMEDIATE HARM TO THE SUBJECT AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349545 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1