BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT CT

    MDR report key: 24403413 · Received February 20, 2026

    Report

    Report Number
    1319211-2026-00047
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    September 23, 2020
    Report Date
    April 16, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    UDI-DI
    15051684018197
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2015, THE PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "POWER PORT." IDENTIFIED BY THE FOLLOWING: CATALOG NUMBER: CT96STSD-VI, LOT NUMBER: 4838077, LABEL PN 103035 REV. A, ANGIODYNAMICS, INC, FOR THE PURPOSES OF THE PLAINTIFF'S CONTINUED MEDICAL TREATMENT FOR SICKLE CELL ANEMIA AT A MEDICAL FACILITY LOCATED IN (B)(6). THIS ANGIODYNAMICS' DEVICE SUBSEQUENTLY CAUSED AN INFECTION TO DEVELOP IN THE PLAINTIFF. ACCORDINGLY, ON (B)(6) 2020, SURGERY WAS PERFORMED TO REMOVE THE PORT CATHETER, AND THE PLAINTIFF UNDERWENT EXTENSIVE TREATMENT FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473347 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC. H787CT96STSDVI1 4838077 15051684018197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| L| O| R