BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLENZ CAPILLARY MAINTENANCE SOLUTION KIT

    MDR report key: 2132935 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02278
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JCB
    PMA / PMN Number
    CL. I EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BECKMAN COULTER WAREHOUSE IN (B)(4) REPORTED THAT THE BOTTLES OF CLENZ SOLUTION WERE LEAKING FROM AN UNKNOWN SOURCE. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLENZ CAPILLARY MAINTENANCE SOLUTION KIT CLENZ SOLUTION JCB BECKMAN COULTER INC. NA 169180F

    Patients

    Seq Age Sex Outcome Treatment
    1