BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® WASH CONCENTRATE BOTTLE

    MDR report key: 1961913 · Received January 14, 2011

    Report

    Report Number
    2050012-2011-00169
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A WASH CONCENTRATE BOTTLE REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE SYNCHRON WASH CONCENTRATE BOTTLE BROKE AND LEAKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® WASH CONCENTRATE BOTTLE REAGENT - WASH CONCENTRATE BOTTLE JJE BECKMAN COULTER INC. NA T007193

    Patients

    Seq Age Sex Outcome Treatment
    1