BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC, PAS, TLR SET

    MDR report key: 2132735 · Received June 7, 2011

    Report

    Report Number
    1722028-2011-00168
    Event Type
    Other
    Date Received
    June 7, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 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-PROGRESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SAMPLE BAG TUBING DETACHED FROM THE CONNECTOR. IT HAPPENED WHEN THE NURSE PUT DOWN THE SAMPLE BAG NEXT TO THE DONOR'S ARM. BLOOD SPILLED ON THE NURSE'S BLOUSE AND TROUSERS. THE CUSTOMER SAYS THE NURSE DID NOT PULL ON THE TUBING. THE DONOR'S AGE AND WEIGHT ARE NOT AVAILABLE AT THIS TIME. THE KIT WAS RETURNED FOR EVAL. THIS REPORT IS BEING FILED DUE TO BLOOD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC, PAS, TLR SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 03T3101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other