BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTO-STAT/CLONE (C-S) I3-RD1

    MDR report key: 2120750 · Received June 10, 2011

    Report

    Report Number
    1061932-2011-00592
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MVU
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT, UPON RECEIVING, LIQUID WAS LEAKING FROM THE CYTO-STAT/CLONE (C-S) (B)(4). THE LIQUID ADHERED TO THE LABEL. THERE WAS NO DEATH OR INJURY TO THE OPERATOR AS A RESULT OF THIS INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES AND THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE): GLOVES, LAB COAT AND GOGGLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTO-STAT/CLONE (C-S) I3-RD1 CYTO-STAT/CLONE (C-S) I3-RD1 REAGENT MVU BECKMAN COULTER, INC. N/A 7354006F

    Patients

    Seq Age Sex Outcome Treatment
    1