BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7874781 · Received September 13, 2018

    Report

    Report Number
    1319681-2018-00095
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    August 21, 2018
    Report Date
    November 2, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN WAS INITIALLY REPORTED THAT THE CUSTOMER WAS SPLASHED IN THE EYE WITH LIQUID WASTE FLUID BUT IT WAS LATER CONFIRMED THAT THE CUSTOMER WAS SPLASHED IN THE EYE WITH FLUID FROM A TIP JAMMED IN THE TIP SEALER. THE INVESTIGATION CONCLUDES THAT AN OPERATOR WAS SPLASHED IN THE EYE WITH FLUID FROM A TIP JAMMED IN THE TIP SEALER WHILE CLEANING THE TIP SEALER ON THE VITROS 5600 INTEGRATED SYSTEM. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT, BUT WAS NOT WEARING A FACE MASK OR EYE PROTECTIVE EQUIPMENT. USER ERROR ASSOCIATED WITH NOT WEARING PROTECTIVE EYEWEAR CONTRIBUTED TO THIS EVENT. THE INVESTIGATION CONCLUDED THAT THE INCIDENT DID INVOLVE BLOOD BORNE PATHOGEN EXPOSURE TO THE SKIN AND MUCOSA. DUE TO THE UNKNOWN PATHOGEN CONTENTS AND PATHOGEN CONCENTRATIONS IN THE FLUIDS, THE POTENTIAL OF INFECTION DUE TO THE EVENT CANNOT BE RULED OUT; HOWEVER THE PROBABILITY OF INFECTION SHOULD BE LOW. THE OPERATOR HAD EYE IRRITATION AND WAS ASSESSED IN THE EMERGENCY ROOM. THE TREATMENT RECEIVED IN THE EMERGENCY ROOM WAS AN EYE WASH AND BLOOD DRAW FOR STANDARD EXPOSURE BASELINE. THE LABORATORY PERSON WILL HAVE FOLLOW UP TESTING DONE IN 6 WEEKS. THE LABORATORY PERSON HAS NOT SOUGHT ANY FURTHER TREATMENT FOR ISSUES CAUSED BY THE EXPOSURE.

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT AN OPERATOR WAS SPLASHED IN THE EYE WITH FLUID FROM A TIP JAMMED IN THE TIP SEALER WHILE CLEANING THE TIP SEALER ON THE VITROS 5600 INTEGRATED SYSTEM.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT AN OPERATOR WAS SPLASHED IN THE EYE WITH LIQUID WASTE FLUID FROM THE VITROS 5600 INTEGRATED SYSTEM. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT, BUT WAS NOT WEARING A FACE MASK OR EYE PROTECTIVE EQUIPMENT. USER ERROR ASSOCIATED WITH NOT WEARING PROTECTIVE EYEWEAR AND PLACING THE WASTE TUBING DIRECTLY INTO THE WASTE BOTTLE INSTEAD OF INTO THE WASTE CAP AS INTENDED WERE CONTRIBUTING FACTORS TO THIS EVENT. THE INVESTIGATION CONCLUDED THAT THE INCIDENT DID INVOLVE BLOOD BORNE PATHOGEN EXPOSURE TO THE SKIN AND MUCOSA. DUE TO THE UNKNOWN PATHOGEN CONTENTS AND PATHOGEN CONCENTRATIONS IN THE WASTE, THE POTENTIAL OF INFECTION DUE TO THE EVENT CANNOT BE RULED OUT; HOWEVER THE PROBABILITY OF INFECTION SHOULD BE LOW. THE OPERATOR HAD EYE IRRITATION AND WAS ASSESSED HOWEVER THE LABORATORY MANAGER DID NOT BELIEVE THAT THE OPERATOR RECEIVED TREATMENT, ALTHOUGH, THIS COULD NOT BE DEFINITELY CONFIRMED.

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT AN OPERATOR WAS SPLASHED IN THE EYE WITH LIQUID WASTE FLUID FROM THE VITROS 5600 INTEGRATED SYSTEM. THIS EVENT CONSTITUTES BIOHAZARD EXPOSURE AND IS CONSIDERED A POTENTIAL SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712911 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1