BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS CHEMISTRY PRODUCTS DT CONTROL II

    MDR report key: 1839423 · Received September 21, 2010

    Report

    Report Number
    1319808-2010-00017
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 25, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS REPORTED AS A POTENTIAL BIOHAZARD EXPOSURE. THE FOLLOWING INFORMATION APPEARS IN THE INSTRUCTIONS FOR USE (IFU) FOR VITROS CHEMISTRY PRODUCTS DT CONTROLS, WHICH INDICATES "HANDLE AS IF CAPABLE OF TRANSMITTING DISEASE. THIS PRODUCT IS PREPARED FROM HUMAN SERUM. EACH DONOR UNIT USED IN THE PREPARATION OF THE PRODUCT HAS BEEN TESTED AND FOUND TO BE NONREACTIVE FOR (B)(6) SURFACE ANTIGEN ((B)(6)), ANTIBODY TO (B)(6), AND ANTIBODY TO (B)(6) USING FDA APPROVED METHODS. HOWEVER, SINCE NO TEST CAN OFFER COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT, THIS PRODUCT SHOULD BE HANDLED FOLLOWING THE RECOMMENDATIONS MADE IN NCCLS GUIDELINE (B)(4) OR OTHER PUBLISHED BIOHAZARD SAFETY GUIDELINES. THIS PRODUCT SHOULD BE HANDLED USING THE SAME PRECAUTIONS AS WITH ANY OTHER BLOOD OR BLOOD-DERIVED PRODUCT." IN THIS EVENT, THE OPERATOR WAS HANDLING A TEST TUBE CONTAINING A FROZEN ALIQUOT OF DT CONTROL II. THE GLASS TUBE BROKE, AND A PIECE OF GLASS ENTERED THE OPERATOR'S LEFT THUMB. THE OPERATOR REMOVED THE GLASS, FLUSHED THE CUT WITH HYDROGEN PEROXIDE, AND BANDAGED THE CUT. NO FURTHER MEDICAL ATTENTION WAS OBTAINED, AND THERE IS NO SERIOUS, LONG TERM OR PERMANENT INJURY. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER RECEIVED A LACERATION TO THEIR THUMB WHILE HANDLING A TEST TUBE CONTAINING VITROS DT CONTROL II. THIS EVENT CONSTITUTES POTENTIAL BIOHAZARD EXPOSURE, AS THERE IS NOT COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS DT CONTROL II IN-VITRO DIAGNOSTIC CONTROL JIT ORTHO-CLINICAL DIAGNOSTICS M8954

    Patients

    Seq Age Sex Outcome Treatment
    1