BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® NO FOAM

    MDR report key: 2232082 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04699
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LDT
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAP WAS LOOSE ON THE NO FOAM BOTTLE. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER INC (BEC) JAPAN REPORTED NO FOAM BOTTLE LEAK. PERSONAL PROTECTIVE EQUIPMENT WAS WORN DURING THE EVENT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® NO FOAM GENERAL PURPOSE REAGENT LDT BECKMAN COULTER INC. NO FOAM KIT M105028

    Patients

    Seq Age Sex Outcome Treatment
    1