BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2092909 · Received May 5, 2011

    Report

    Report Number
    1722028-2011-00120
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 COMPLAINED ABOUT THE NEEDLE GUARD ON THE TRIMA DISPOSABLE SET. THE CUSTOMER STATED THAT THE BUTTERFLY WINGS ARE NOT ALWAYS ALIGNED WITH THE SLEEVES ON THE PROTECTOR, THEREFORE, THEY SOMETIMES HAVE TO REPOSITION THEM, WHICH CREATES A HAZARD. TWO NURSES HAVE STUCK THEMSELVES DOING SO. CARIDIANBCT IS AWAITING FURTHER INFO FROM THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other