BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4C -ES CELL CONTROL

    MDR report key: 2133420 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00582
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K010064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER PRODUCT LABELING: THIS REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988. THE OPERATOR STATED THAT HE WAS UNSURE IF THE CAP WAS NOT ON CORRECTLY OR IF IT WAS CRACKED, BECAUSE WHEN HE NOTICED THE SPILLING, HE DROPPED THE VIAL AND IT BROKE ON THE FLOOR. THE VIAL WAS UNAVAILABLE FOR FURTHER ANALYSIS. ROOT CAUSE FOR THE LEAKAGE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL BIOHAZARD EVENT WHILE USING THE 4C -ES CELL CONTROL. WHILE INVERTING THE HIGH LEVEL CONTROL VIAL FOR MIXING, THE VIAL LEAKED ONTO THE OPERATOR'S PANTS AND CAME IN CONTACT WITH HIS SKIN. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. THE OPERATOR WAS UNSURE WHETHER THE VIAL LEAKED DUE TO A LOOSE CAP OR IF IT WAS CRACKED. THE OPERATOR STATED HE WOULD GO TO THE FACILITY'S OCCUPATIONAL HEALTH OFFICE. IT IS UNK IF TREATMENT WAS REQUIRED WHEN THE OPERATOR WENT TO THE FACILITY'S OCCUPATIONAL HEALTH OFFICE, THEREFORE MEDICAL INTERVENTION MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4C -ES CELL CONTROL JPK BECKMAN COULTER, INC. NA 089000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COULTER AC- T DIFF 2 ANALYZER