BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTI-D BIOCLONE

    MDR report key: 1735502 · Received June 24, 2010

    Report

    Report Number
    2250051-2010-00155
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PROVIDED INFORMATION REGARDING VIRAL TESTING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A BLOOD BANK TECH CUT HER FINGER WHEN ATTEMPTING TO OPEN A TEST TUBE CONTAINING (B)(4). CUSTOMER STATES THAT THE TECH HAD THE TUBE IN HER HAND AND IT BROKE AND CUT HER FINGER. TECH WAS EXPOSED TO THE ANTISERUM. CUSTOMER STATES THAT THE TECH WAS TREATED IN THE EMERGENCY ROOM AND INCIDENT WAS REPORTED TO THE HOSPITAL RISK MANAGEMENT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D BIOCLONE BLOOD GROUPING REAGENTS KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1