BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH

    MDR report key: 1241536 · Received November 21, 2008

    Report

    Report Number
    1518293-2008-00353
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 29, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: COVIDIEN PRODUCT MONITORING ASKED CUSTOMER IF THEY FELT THE INJECTOR MAY HAVE CAUSED THE ADVERSE EVENT, THEY STATED NO. PM ASKED CUSTOMER IF THEY WANTED SERVICE TO EVALUATE THE INJECTOR AND PERFORM A SYSTEMS CHECK, THEY AGAIN STATED NO. CUSTOMER FELT THAT IV LOCATION WAS WHAT INFLUENCED THE IV INFILTRATION, NOT THE INJECTOR SYSTEM AND THEY WILL CONTINUE TO USE THE INJECTOR SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE, A MALE, ICU PATIENT, HAVING A CT ABDOMEN/PELVIS WITH CONTRAST POSTOP FOR LEUCOCYTOSIS. IV ACCESS WAS IN THE LEFT FOREARM WITH A 20GA ANGIOCATH, CONNECTED TO "Y" TUBING WITH A B-D LEVER-LOK NEEDLELESS ADAPTOR. INJECTOR WAS LOADED WITH OPTIRAY 300, 100ML PREFILLED SYRINGE (P244C, EXP. 05/2010). INJECTION PROTOCOL, 1.5ML/SEC FOR 90ML VOLUME. INJECTION STARTED. TECHNOLOGIST DID NOT SEE ANY CONTRAST ON THE CT IMAGES, THEN NOTED PATIENT FOREARM SWOLLEN WITH NO REDNESS AND PATIENT DID NOT EXPRESS ANY PAIN OR DISCOMFORT. WARM COMPRESS APPLIED AND EXTREMITY ELEVATED. PATIENT RETURNED TO ICU WITH STAFF NURSE WITH INSTRUCTIONS FROM RADIOLOGIST TO OBSERVE AND TREAT AS NECESSARY. PM ASKED CUSTOMER IF THEY FELT THE INJECTOR MAY HAVE CAUSED THE ADVERSE EVENT, THEY STATED NO. PM ASKED CUSTOMER IF THEY WANTED SERVICE TO EVALUATE THE INJECTOR AND PERFORM A SYSTEMS CHECK, THEY STATED NO. CUSTOMER FELT IT WAS THE CONDITION OF THE PATIENT AND IV LOCATION THAT INFLUENCED THE IV INFILTRATION, NOT THE INJECTOR SYSTEM AND THEY WILL CONTINUE TO USE THE INJECTOR SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention