BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 2052063 · Received March 1, 2011

    Report

    Report Number
    1518293-2011-00028
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED A SYRINGE BROKE AROUND THE FLANGE AND "SHOT OUT OF INJECTOR". CUSTOMER DID NOT NOTICE ANY ALERT MESSAGES, WHEN THE INCIDENT OCCURRED. CUSTOMER DECIDED NOT TO HAVE A FIELD SERVICE ENGINEER (FSE) EVALUATE THE INJECTOR, AS THEY DO NOT FEEL THE INJECTOR FAILED IN ANY MANNER.

    Description of Event or Problem · 1

    (B)(6): CUSTOMER REPORTS VIA PHONE, APPROX (B)(6), MALE, PATIENT, HAVING A CT CHEST WHEN THE PREFILLED CONTRAST MEDIA SYRINGE FLANGE BROKE AND SYRINGE POPPED OFF THE INJECTOR, JUST MISSING HITTING THE PATIENT. STAFF RELOADED THE INJECTOR WITH A NEW SYRINGE, PERFORMED THE PROCEDURE WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTOR, OPTIVANTAGE DH W/RFID CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OPTIRAY-350 20X100ML PI SYR