BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL PLATELET SET

    MDR report key: 1952176 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00148
    Date Received
    December 29, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K900105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO OTHER INFORMATION AVAILABLE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON SIX OCCASIONS, NEEDLE DISPLACEMENT HAS OCCURRED. ON ALL EVENTS, THERE WAS A HIGH RETURN PRESSURE ALARM AND ON INSPECTION OF THE VENIPUNCTURE SITE, THE NEEDLE HAD MOVED OUT OF THE VEIN AND THE PROCEDURE WAS STOPPED. THIS REPORT IS BEING SUBMITTED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLATELET SET SEPARATOR, AUTOMATED, BLOOD AND PLA LKN CARIDIANBCT 09S9106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other