BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3092347 · Received May 3, 2013

    Report

    Report Number
    1722028-2013-01182
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND ANALYSIS, SO THE ENGAGEMENT OF THE NEEDLEGUARD COULD NOT BE EVALUATED. THERE HAVE BEEN NO OTHER REPORTS OF NEEDLE GUARD ISSUES OR NEEDLESTICKS ON THIS DISPOSABLE LOT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE DISPOSABLE SET WAS NOT RETURNED. BASED ON THE INFORMATION FROM THE CUSTOMER AND THE TREND REVIEW OF THIS DISPOSABLE LOT,IT IS LIKELY THAT THE NEEDLE WAS NOT FULLY ENGAGED IN THE NEEDLE GUARD WHEN IT WAS PLACED IN THE BIOHAZARD WASTE. CORRECTION: THE SERVICE REPRESENTATIVE WAS MADE AWARE OF THIS ISSUE AND RETRAINED ON THE CORRECT USE OF THE NEEDLE GUARD AND SHARPS PROTECTION. THE CUSTOMER APPLIED BRIGHT STICKERS WITH THE WORDS "NO SHARPS" ON THEIR BIOHAZARD CONTAINERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A TERUMO BCT SERVICE REPRESENTATIVE REPAIRED THEIR TRIMA MACHINE, HE DISCARDED THE NEEDLE USED DURING THE SALINE RUN INTO THE BIOHAZARD BAG INSTEAD OF THE SHARPS CONTAINER, AND DID NOT ENGAGE THE NEEDLE GUARD. WHEN THE OPERATOR WAS REMOVING THE BIOHAZARD BAG, SHE GOT POKED BY THE NEEDLE. THE BIOHAZARD BAG CONTAINED BLOODY INTACT DISPOSABLES. PER THE CUSTOMER'S PROCEDURES, THEY FOLLOWED THE PROTOCOL FOR A DIRTY NEEDLE STICK. INFECTIOUS DISEASE TESTING WAS DONE, WITH FOLLOW-UP TESTING PLANNED FOR 3, 6 AND 12 MONTHS. THE OPERATOR WAS HEALTHY AT THE TIME OF THE NEEDLE STICK AND ALL BASELINE TESTING WAS NEGATIVE. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT (OPERATOR) ID, AGE OR WEIGHT. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION, IN THE FORM OF SERVICE REP ERROR, THAT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR INJURY IF THIS SAME FAILURE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195129 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 02V1122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other