BEUDAMED
    FDA Adverse Event Other Summary report: N

    VORTEX SUBCUTANEOUS PORT

    MDR report key: 118073 · Received September 5, 1997

    Report

    Report Number
    1450392-1997-90003
    Event Type
    Other
    Date Received
    September 5, 1997
    Date of Event
    March 14, 1997
    Report Date
    July 18, 1997
    Manufacturer
    NORFOLK MEDICAL
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    03/14/97: DOUBLE LUMEN PORT INSERTED FLUSHED & DREW BLOOD IN OR. 03/14/97: LATER IN DAY: LATERAL PORT DIFFICULTY DRAWING BLOOD. 03/16/97: DECEASED AFTER FLUSHING. 04/18/97: BOTH PORTS ACCESSED LATERAL PORT HARD TO FLUSH BOTH DREW BLOOD WORK. 06/06/97: BOTH PARTS ACCESSED LATERAL PORT HARD TO ASPIRATE AND FLUSH DECLOT ATTEMPT WITH UROKINASE UNSUCCESSFUL. 06/07/97: UROKINASE DECLOT AGAIN UNSUCCESSFUL. 07/18/97: PORT EXPLANTED: DEVICE NTOED TO BE ABNORMAL ANOTHER PART IMPLANTED..

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention