BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 6568551 · Received May 16, 2017

    Report

    Report Number
    1319681-2017-00037
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    April 19, 2017
    Report Date
    May 16, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT A WASTE FLUID THAT LIKELY CONTAINED PATIENT SAMPLE SPLASHED ONTO THE VITROS OPERATOR¿S FACE WHILE EMPTYING THE MICROWELL LIQUID WASTE CONTAINER. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR, AS THE VITROS OPERATOR DID NOT USE PROPER PERSONAL PROTECTION EQUIPMENT (SAFETY GLASSES OR FACE MASK) WHILE EMPTYING THE MICROWELL LIQUID WASTE CONTAINER. UNDER THE DAILY MAINTENANCE PROCEDURE OF THE ON-BOARD USER DOCUMENTATION (VDOCS), THE FOLLOWING WARNING IS DISPLAYED: ¿DANGER: THE LIQUID WASTE BOTTLE WILL CONTAIN TRACE AMOUNTS OF SAMPLE FLUID. HANDLE WASTE AS BIOHAZARDOUS MATERIAL. REMOVE WASTE ACCORDING TO INSTRUCTIONS AND ACCEPTED LABORATORY PROCEDURES.¿ THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A VITROS OPERATOR WAS SPLASHED IN THE EYES BY FLUID FROM THE MICROWELL LIQUID WASTE CONTAINER OF A VITROS 5600 INTEGRATED SYSTEM. A SPLASH OF CLINICAL LABORATORY MEDICAL WASTE TO THE FACE OF A HEALTH CARE WORKER IS CONSIDERED AS BLOOD BORNE PATHOGEN EXPOSURE TO SKIN AND MUCOSA. DUE TO THE UNKNOWN PATHOGEN CONTENTS AND PATHOGEN CONCENTRATIONS IN THE WASTE, THE POTENTIAL OF INFECTION DUE TO THE EXPOSURE CANNOT BE RULED OUT; HOWEVER THE PROBABILITY OF INFECTION SHOULD BE LOW. THE VITROS OPERATOR HAD NO ADVERSE REACTIONS OR SYMPTOMS AS A RESULT OF THIS EVENT, AND NO ADDITIONAL MEDICAL TREATMENT WAS SOUGHT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351580 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1