BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8363865 · Received February 22, 2019

    Report

    Report Number
    1319681-2019-00015
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT AN OPERATOR SUSTAINED A CUT FINGER WHEN MANIPULATING THE MICROWELL INCUBATOR RING ON THE VITROS 5600 INTEGRATED SYSTEM. THE OPERATOR IMMEDIATELY WASHED HER HAND. IT WAS CONFIRMED THE OPERATOR DID NOT NEED STITCHES. THE CUSTOMER STATED THAT THEY WERE WEARING GLOVES AT THE TIME OF THE EVENT. THE OPERATOR REPORTED THEY ARE HAVING LAB TESTING DONE AS A PRECAUTION, NO LONG TERM CONSEQUENCES ARE EXPECTED.

    Description of Event or Problem · 1

    AN OPERATOR SUSTAINED A CUT FINGER WHEN MANIPULATING THE MICROWELL INCUBATOR RING ON THE VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO ALLEGATION OF A SERIOUS OR LONG TERM PERMANENT INJURY. HOWEVER, THERE IS A POTENTIAL THAT THE OPERATOR MIGHT BE EXPOSED TO BLOOD BORNE PATHOGENS AND SHOULD BE CONSIDERED AS A SERIOUS INJURY. PER MEDICAL CONSULT FROM AN ORTHO MEDICAL SAFETY OFFICER, A CUT IS NOT CONSIDERED A SERIOUS INJURY UNLESS IT WOULD AFFECT THE FUNCTION OF THE FINGER/HAND OR IF THERE WAS A CHANCE IN CONTACT WITH BIOHAZARD MATERIALS THROUGH THE CUT. IT WAS STATED THAT THE OPERATOR WAS HAVING CLINICAL LABORATORY TESTING CARRIED OUT AS A PRECAUTION, NO LONG TERM CONSEQUENCES ARE EXPECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157404 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    0 Other