BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOJECTOR 2000

    MDR report key: 726212 · Received June 13, 2006

    Report

    Report Number
    3023012-2006-00002
    Event Type
    Injury
    Date Received
    June 13, 2006
    Date of Event
    May 7, 2006
    Report Date
    May 26, 2006
    Manufacturer
    BIOJECT, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ACCESSORIES WERE RETURNED FOR EVALUATION. THEREFORE, THE LAST SERVICE AND BATCH RECORDS WERE REVIEWED TO DETERMINE IF ANY OUT OF SPECIFICATION CONDITIONS WERE PRESENT IN THE RECORDS THAT COULD HAVE LED TO THE EVENT AS STATED. THE REVIEW CONCLUDED THAT THE BOTH THE DEVICE AND ACCESSORIES MET ALL SPECIFICATIONS REQUIREMENTS. NOTHING WAS FOUND TO SUGGESST THAT A DEVICE MALFUNCTION OR OUT OF SPECIFICATION CONDITON CONTRIBUTED TO THE EVENT. ADDITIONAL COMMUNICATION WITH THE EVNT REPORTER INDICATED THAT THE INNER THIGH MAY HAVE BEEN USED AS THE INJECTION SITE WHICH IS INCONSISTENT WITH PRODUCT LABELING. BASED ON THIS INFORMATION, INCORRECT INJECTION SITE SELECTION IS THE MOST LIKELY CAUSE OF THE EVENT. THIS IS SUPPORTED BY INFORMATION THAT THE PATIENT CONTINUES TO USE THE DEVICE, INJECTING AT OTHER SITES, WITHOUT INCIDENT.

    Description of Event or Problem · 1

    PATIENT SELF-ADMINISTERED AN INJECTION OF FUZEON 90 MG IN THE INNER THIGH USING THE BIOJECTOR 2000, ON THE EVENING OF 05/07.06. THE REPORT SATED THAT THE PATIENT AWOKE AT 1:30 AM WITH ECHYMOSIS, BRUISING AND SWELLING (2X NORMAL SIZE) IN THE LEG FROM PELVIS TO KNEE. A HEMATOMA OF THE MEDICAL ASPECT OF THE THIGH WAS CONFIRMED BY CT SCAN. COAGULATION TESTS (PTT, CBC, AN PLATELETS) WEREWITHIN NORMAL LIMITS. PATIENT IS REPORTED TOHAVECONTINUED USING THE B200 FOR THE ADMINISTRATION OF FUZEON EMPLOYING DIFFERENT INJECTIONS SITES WITHOUT FURTHER INCIDENT. THE HEMATOMA IS RECEDING, SELF-MANAGING AT HOME, TAKING IBUPROFEN FOR DISCOMFORT AS NEEDED, AND AVOIDING FURTHER INJECTION IN HTE INNER THIGH UNTIL COMPLETE RESOLUTION. PATIENT CONTINUED OT HAVE DIFFICULTY WITH MOBILITY ONE WEEK AFTER THE INCIDENT AND WAS RESTRICTED TO BED REST. THE PATIENT HAS BEN USING THE BIOJECTOR 2000 FOR ADMINISTRATION OF FUZEON SINCE DECEMBER OF 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOJECTOR 2000 INJECTOR, FLUID, NON-ELECTRICALLY POWERED KZE BIOJECT, INC. 1B02000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization