BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 20955239 · Received December 17, 2024

    Report

    Report Number
    1319681-2024-00066
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED THAT WASTE FLUID THAT LIKELY CONTAINED PATIENT SAMPLE SPLASHED INTO THE EYE OF AN OPERATOR WHILE EMPTYING AND CLEANING OUT A 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 AND CLEANING OUT 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 VISITED A PHYSICIAN AND WAS ADVISED TO TAKE THE PEP MEDICATION FOR 28 DAYS. THE OPERATOR HAD NO ADVERSE REACTIONS OR SYMPTOMS AS A RESULT OF THE EVENT AND NONE HAVE BEEN REPORTED TO ORTHO. BASED ON A PREVIOUS CONSULTATION WITH THE ORTHO MEDICAL SAFETY OFFICER ON 11 JANUARY 2013 (QERTS IVDA 274516),THIS EVENT IS CONSIDERED A POTENTIAL SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WASTE FLUID, WHICH LIKELY CONTAINED PATIENT SAMPLE, SPLASHED INTO THE EYE OF AN OPERATOR WHILE EMPTYING AND CLEANING OUT A WASTE CONTAINER FROM A VITROS 5600 INTEGRATED SYSTEM. A SPLASH OF CLINICAL LABORATORY MEDICAL WASTE TO THE EYES 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 608399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258813 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown