BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT APPLICABLE

    MDR report key: 1905219 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01351
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JFM
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A D-BIL CARTRIDGES THAT WERE CRACKED AND LEAKING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE NOT APPLICABLE JFM BECKMAN COULTER INC. N/A Z007011

    Patients

    Seq Age Sex Outcome Treatment
    1