BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

    MDR report key: 18367912 · Received December 20, 2023

    Report

    Report Number
    0001319808-2023-00021
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JIX
    UDI-DI
    10758750000166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT WHEN ATTEMPTING TO REMOVE THE ALUMINUM CAP OF A VITROS CALIBRATOR KIT 1, THE VIAL BROKE, AND THE OPERATOR SUSTAINED A SMALL CUT TO THE HAND. THE OPERATOR WAS WEARING A LATEX GLOVE AT THE TIME OF THE INCIDENT. FIRST AID WAS PROVIDED, INCLUDING REMOVING THE GLASS SPLINTER, WOUND CLEANSING, AND BANDAGING. THERE WAS NO FURTHER MEDICAL TREATMENT AT THE TIME OF THE EVENT. UPON FOLLOW-UP WITH THE CUSTOMER, THE OPERATOR STATED THEY WERE OKAY AND THAT THE WOUND HAD ALREADY HEALED. ADDITIONALLY, NO FURTHER MEDICAL TREATMENT WAS REQUIRED FOR THE OPERATOR.

    Description of Event or Problem · 0

    A LABORATORY OPERATOR SUSTAINED A SMALL CUT TO THEIR HAND WHEN ATTEMPTING TO OPEN VIAL 2 OF VITROS CALIBRATOR KIT 1. 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: BASED ON THE SAFETY DATA SHEET, THERE IS A RISK OF ZOONOTIC INFECTION FROM CONTACT WITH ANIMAL BLOOD DERIVATIVES. ALTHOUGH THE MATERIALS FOR MAKING THE REAGENTS WERE TESTED NEGATIVE FOR BLOOD-BORNE PATHOGENS, NO TEST METHOD CAN ASSURE THAT THE PRODUCT IS COMPLETELY SAFE FROM POTENTIAL PATHOGENS. IN ADDITION, THERE MIGHT BE UNKNOWN PATHOGENS OR PATHOGENS THAT WERE NOT TESTED. SO, A DISEASE TRANSMISSION DUE TO THE EXPOSURE CANNOT BE EXCLUDED. THUS, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY DUE TO THE UNCERTAINTY OF INFECTION RISK. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279183 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 IN-VITRO DIAGNOSTICS JIX ORTHO-CLINICAL DIAGNOSTICS, INC. 0152 10758750000166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown