BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL RBC AND PLS SET

    MDR report key: 2092906 · Received May 5, 2011

    Report

    Report Number
    1722028-2011-00116
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    February 28, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE NEEDLE DID NOT LOCK INTO THE NEEDLE GUARD COMPLETELY CENTERED. THE CUSTOMER THEN SEALED THE NEEDLE AND PUT IT INTO THE SHARPS CONTAINER. AS OPERATOR WAS DOING THIS, THE OPERATOR STUCK THE LITTLE FINGER ON THE OPERATOR'S RIGHT HAND JUST ENOUGH TO BREAK THE SKIN. THE OPERATOR WAS GIVEN CARE PER THEIR SOP'S AND THE FINGER HEALED FINE. THE TUBING SET WAS NOT AVAILABLE FOR RETURN. NO PT INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL RBC AND PLS SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 12S2101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other