BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX SUBCUTANEOUS PORT

    MDR report key: 111826 · Received August 4, 1997

    Report

    Report Number
    111826
    Event Type
    Injury
    Date Received
    August 4, 1997
    Date of Event
    March 14, 1997
    Report Date
    July 18, 1997
    Manufacturer
    NORFOLK MEDICAL
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    031497 DOUBLE LUMEN PORT INSERTED FLUSHED AND DREW BLOOD IN OR. 031497 LATER IN DAY: LATERAL PORT DIFFICULT DRAWING BLOOD. 031697 DECEASED AFTER FLUSHING. 041897 BOTH PORTS ACCESSED. LATERAL PORT HARD TO FLUSH. BOTH DREW BLOOD WELL. 060697 BOTH PORTS ACCESSED. LATERAL PORT HAD TO ASPIRATE AND FLUSH. DECLOT ATTEMPT WITH UROKINASE UNSUCCESSFUL. 060797 UROKINASE DECLOT AGAIN UNSUCCESSFUL. 071897 PORT EXPLANTED - DEVICE NOTED TO BE ABNORMAL. ANOTHER PORT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX SUBCUTANEOUS PORT Implant IMPLANTED PORT (VENOUS) LJT NORFOLK MEDICAL P5955 961101

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention