BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 3

    MDR report key: 14523568 · Received May 27, 2022

    Report

    Report Number
    3007111389-2022-00050
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 27, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED AN ORTHO FIELD ENGINEER (FE) SUSTAINED A CUT TO THEIR RIGHT-HAND THUMB FROM A METAL CAP WHEN ATTEMPTING TO OPEN A VIAL OF VITROS CALIBRATOR KIT 3. THE ORTHO FE WAS NOT WEARING GLOVES AT THE TIME OF THE EVENT. THE CUT WAS WASHED WITH WATER AND BANDAGED. THE FE DID NOT RECEIVE MEDICAL TREATMENT FOR THE CUT AND THAT THE CURRENT CONDITION OF THE FE IS OKAY. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED AN ORTHO FIELD ENGINEER (FE) SUSTAINED A CUT TO THEIR RIGHT-HAND THUMB FROM A METAL CAP WHEN ATTEMPTING TO OPEN A VIAL OF VITROS CALIBRATOR KIT 3. BASED ON A MEDICAL CONSULT WITH ORTHO MEDICAL SAFETY OFFICER, DR (B)(4) ON 06 MAY 2022 REGARDING THE EVENT, IF THE AFFECTED THUMB HAD DIRECT CONTACT WITH THE COMPONENTS IN THE VIAL OF THE CALIBRATOR KIT, SINCE THE SDS STATES THAT THIS PRODUCT CONTAINS HUMAN BLOOD DERIVATIVES AND NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS. THEREFORE, ORTHO IS DECIDING TO CONSERVATIVELY CLASSIFY THIS EVENT AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753955 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 3 IN-VITRO DIAGNOSTICS JIX ORTHO-CLINICAL DIAGNOSTICS 0331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown