BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 21101474 · Received January 8, 2025

    Report

    Report Number
    21101474
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 7, 2025
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PORT REMOVAL. PATIENT RETURNED TO ED WITH PAIN AT PORT SITE. PORT CATHETER CONNECTOR WAS RETAINED IN THE SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235991 XCELA PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. H965451830 152926

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA Female Hospitalization