BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 10384857 · Received August 10, 2020

    Report

    Report Number
    1319681-2020-00064
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 10, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT WASTE FLUID THAT LIKELY CONTAINED PATIENT SAMPLE SPLASHED INTO THE EYE OF AN OPERATOR WHILE EMPTYING THE WASTE CONTAINER FROM A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR, AS THE OPERATOR DID NOT USE PROPER PERSONAL PROTECTIVE EQUIPMENT (SAFETY GLASSES OR FACE SHIELD) WHILE EMPTYING THE WASTE CONTAINER. UNDER THE DAILY MAINTENANCE PROCEDURE OF THE ON-BOARD USER DOCUMENTATION (VDOCS), IT WARNS THAT THE WASTE CONTAINER WILL CONTAIN TRACE AMOUNTS OF SAMPLE FLUID. HANDLE WASTE AS BIOHAZARDOUS MATERIAL. REMOVE WASTE ACCORDING TO INSTRUCTIONS AND ACCEPTED LABORATORY PROCEDURES. THE INVESTIGATION CONCLUDED THAT THE INCIDENT INVOLVED EXPOSURE TO MUCOSAL TISSUE WITH THE WASTE FLUID. THEREFORE, THE POTENTIAL FOR A BLOOD BORNE PATHOGEN INFECTION DUE TO THE EVENT CANNOT BE RULED OUT. THE OPERATOR HAD NO ADVERSE REACTIONS OR SYMPTOMS AS A RESULT OF THIS EVENT. THE CUSTOMER STATED THAT NO FURTHER TREATMENT FOR THE OPERATOR WAS SCHEDULED OR EXPECTED.

    Description of Event or Problem · 1

    AN OPERATOR WAS EMPTYING A WASTE CONTAINER FROM A VITROS 5600 INTEGRATED SYSTEM INTO A SINK. WHILE EMPTYING THE CONTAINER, SOME FLUID SPLASHED INTO ONE OF THE OPERATOR¿S EYES. THE OPERATOR WENT TO THE EMERGENCY ROOM (ER) WHERE THEIR EYES WERE FLUSHED FOR 15 MINUTES AND THEY WERE GIVEN EYE DROPS. THE OPERATOR WAS NOT WEARING SAFETY GLASSES OR A FACE SHIELD. UNDER THE DAILY MAINTENANCE PROCEDURE OF THE ON-BOARD USER DOCUMENTATION (VDOCS), IT WARNS THAT THE WASTE CONTAINER WILL CONTAIN TRACE AMOUNTS OF SAMPLE FLUID. HANDLE WASTE AS BIOHAZARDOUS MATERIAL. REMOVE WASTE ACCORDING TO INSTRUCTIONS AND ACCEPTED LABORATORY PROCEDURES. THE OPERATOR HAD NO ADVERSE REACTIONS OR SYMPTOMS AS A RESULT OF THIS EVENT, AND NO ADDITIONAL MEDICAL TREATMENT WAS SOUGHT. THE CUSTOMER STATED THAT NO FURTHER TREATMENT FOR THE OPERATOR WAS SCHEDULED OR EXPECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848197 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other