BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED CELL LYSING REAGENT

    MDR report key: 2210826 · Received August 12, 2011

    Report

    Report Number
    1061932-2011-01175
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GGK
    PMA / PMN Number
    CLAS1 EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO APPARENT SHIPPING DAMAGE WAS NOTED. SERVICE WAS NOT DISPATCHED. ROOT CAUSE IS UNKNOWN FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. (BEC) OPERATOR REPORTED RECEIVING BOTTLE OF ACT 5 DIFF WBC LYSE BOTTLE WHICH HAD LEAKED FORM THE BOTTOM CAUSING DAMAGE TO SIX OTHER BOTTLE LABELS. THE OPERATOR WAS WEARING GLOVED AT THE TIME OF THE INCIDENT. NO EXPOSURE, OR CONTACT WITH THE EYES OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANES. THE MSDS WAS REVIEWED AND THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RED CELL LYSING REAGENT RED CELL LYSING REAGENT. GGK BECKMAN COULTER INC. ACT 5 DIFF WBC LYSE 15202B

    Patients

    Seq Age Sex Outcome Treatment
    1