BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPORT PLASTIC LOW PROFILE PORT WITH VORTEX TECHNOLOGY

    MDR report key: 19709633 · Received July 10, 2024

    Report

    Report Number
    19709633
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 21, 2024
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PORT WAS IMPLANTED BY SURGEON AS PER MANUFACTURER INSTRUCTIONS. IN PACU (POST-ANESTHESIA CARE UNIT), IT WAS DETERMINED THAT PORT WAS NOT WORKING. PATIENT WAS SENT TO IR (INTERVENTIONAL RADIOLOGY). THE CATHETER DETACHED FROM THE PORT AND WAS LODGED IN SVC (SUPERIOR VENA CAVA). FOREIGN BODY WAS RETRIEVED, NEW PORT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282738 SMARTPORT PLASTIC LOW PROFILE PORT WITH VORTEX TECHNOLOGY PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. CT80LPPDVI 5800486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown