BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI WASH BUFFER II

    MDR report key: 2032008 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00815
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR HIS EVENT. BCI CONTACTED THE INTERNATIONAL REPRESENTATIVE FOR AN UPDATE ON THE CUSTOMER'S HEALTH. HOWEVER, NO RESPONSE WAS RECEIVED TO DATE. NOTE: THE PRODUCT IS SOLD IN CONTAINERS THAT HAVE A VOLUME OF 10 LITERS. THE PRODUCT'S VOLUME IS PRINTED ON THE LABEL ATTACHED TO THE PRODUCT. HANDLES ARE PROVIDED TO USE IN MOVING THE CONTAINERS. THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY BECKMAN COULTER, INC. BY SUBMITTING THIS REPORT, THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED IS DEFECTIVE. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE WASH BUFFER II CUBETAINER HANDLES WERE DIFFICULT FOR THE CUSTOMER TO PUNCTURE, THEREFORE THEY WERE ATTEMPTING TO MOVE IT WITHOUT USING THE PROVIDED HANDLES. DURING THIS ACTIVITY THE CUBETAINER SLIPPED AND THE TECHNICIAN SUFFERED A BACK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI WASH BUFFER II WASH BUFFER II JJE BECKMAN COULTER INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other