BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 3233986 · Received July 16, 2013

    Report

    Report Number
    1518293-2013-00154
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 16, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013: CUSTOMER REPORTS VIA PHONE THAT DURING A CT ABD/PELVIS ON (B)(6) FEMALE OUTPATIENT, THEY EXPERIENCED A CONTRAST INFILTRATION. IV ACCESS WAS IN THE RIGHT WRIST WITH A 22GA. INTRACATHETER. OPTIRAY 320, 100ML PREFILLED SYRINGE WAS LOADED ONTO THE INJECTOR AND THE PROTOCOL OF 1.7ML/SEC FOR A VOLUME 100ML WAS SELECTED, WITH 300PSI SET. APPROXIMATELY 69ML WAS INJECTED WHEN THE INJECTOR STALLED AT 150PSI. STAFF DID SEE CONTRAST ON THE IMAGES, BUT DO NOT KNOW THE AMOUNT OF FLUID INFILTRATED. RADIOLOGIST AND REGISTERED NURSE CALLED TO EVALUATE THE PATIENT, WHO WAS COMPLAINING OF PAIN, WITH THE WRIST SWOLLEN AND RED. STAFF TREATED WITH AN ICE PACK FOR APPROXIMATELY TWO HOURS, WHILE ATTEMPTING TO GET A SURGICAL CONSULT. PATIENT WAS SENT TO (B)(6) HOSPITAL TO OBTAIN THE SURGICAL CONSULT, WHERE NO SURGICAL INTERVENTION WAS TAKEN. CUSTOMER SAID THE FSE TOLD HER COVIDIEN WOULD BE REPORTING TO THE FDA, AND THEIR QUALITY DEPARTMENT HAS REQUESTED COPY OF FDA SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329102 INJECTOR, OPTIVANTAGE DH W/RFID IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other