BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOJECTOR 2000

    MDR report key: 963815 · Received December 6, 2007

    Report

    Report Number
    3023012-2007-00001
    Event Type
    Injury
    Date Received
    December 6, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 27, 2007
    Manufacturer
    BIOJECT, INC.
    Product Code
    KZE
    PMA / PMN Number
    K861687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED TO ADMINISTER THE INJECTION WAS ONE OF 12 USED BY THE SITE. THE SITE WAS UNABLE TO DETERMINE WHICH OF THE 12 THE DEVICE WAS. DEVICE HISTORY RECORDS OF ALL 12 DEVICES WERE REVIEWED AND ALL DEVICES WERE FOUND TO BE WITHIN SPECIFICATIONS. THE 12 DEVICES WERE SHIPPED TO THE SITE IN 2004. DURING THREE YEARS OF USE, NONE OF THE 12 DEVICES HAVE RESULTED IN A SEPARATE COMPLAINT FOR INJURY, INDICATING THAT THE INJURY IS NOT LIKELY DUE TO CHRONIC MALFUNCTION. THE PATIENT WAS REPORTED TO BE ON ANTI-PLATELET/ANTICOAGULANT THERAPY. THE PRODUCT'S INSTRUCTIONS FOR USE INCLUDES PRECAUTIONS REGARDING USE WITH PATIENTS ON ANTICOAGULANTS. IT STATES "PATIENTS RECEIVING ANTICOAGULANTS OR PERSONS WITH HEMOPHILIA, OR OTHER COAGULATION DISORDERS, MAY PRESENT GREATER INCIDENT OF POST-INJECTION BLEEDING. FOR THESE PATIENTS, TAKE THE SAME PRECAUTIONS AND ADMINISTER THE APPROPRIATE TREATMENT AS WHEN USING A NEEDLE AND SYRINGE FOR INJECTION." NONE OF THESE 12 DEVICES HAD BEEN RETURNED BY THE SITE TO THE MANUFACTURER FOR THE 18-MONTH SERVICE AS RECOMMENDED IN THE PRODUCT INSTRUCTIONS FOR USE. THE SITE WAS ADVISED TO RETURN ALL DEVICES FOR SERVICE AND EVALUATION BUT NONE WERE RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A PATIENT WHO WAS ON COUMADIN AND PLAVIX RECEIVED A FLU VACCINATION WITH THE BIOJECTOR 2000. THE PATIENT'S HUSBAND INFORMED THE SITE THE FOLLOWING DAY THAT HER RIGHT ARM SWELLED AND WAS BLACK AND BLUE FROM HER FINGERS TO HER SHOULDER AND AROUND HER BACK, AND SHE NEEDED 5 UNITS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOJECTOR 2000 NONE KZE BIOJECT, INC. 1BO2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other NONE REPORTED