BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC FRENCH SET

    MDR report key: 2132747 · Received June 10, 2011

    Report

    Report Number
    1722028-2011-00171
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 17, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REPORTED THAT DURING A PROCEDURE, THE NEEDLE RETRACTOR WAS NOT FUNCTIONAL, AND ALLEGED A RISK OF BLOOD EXPOSURE. THE PT INFO IS NOT AVAILABLE AT THIS TIME. CARIDIANBCT IS AWAITING THE RETURN OF THE DISPOSABLE SET. THIS REPORT IS BEING FILED DUE TO AN ALLEGATION OF A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC FRENCH SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 03T3129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other