BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT CT

    MDR report key: 25230100 · Received May 20, 2026

    Report

    Report Number
    1319211-2026-00176
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    June 29, 2022
    Report Date
    May 20, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    UDI-DI
    15051684018036
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PORT CATHETER PRODUCT, MODE NUMBER CT80STPD. THE SMARTPORT WAS IMPLANTED ON THE LEFT SIDE OF HER CHEST BY DR. (B)(6), MD, AT (B)(6) IN WARREN, OHIO. IN OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED TO (B)(6) IN WARREN, OHIO, WITH SWELLING AND PAIN IN HER LEFT CHEST AS WELL AS SIGNIFICANT AXILLARY TENDERNESS. HER MEDICAL TEAM DETERMINED THAT SHE HAD AN INFECTION. THE PORT WAS SUBSEQUENTLY REMOVED IN (B)(6), 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108908 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC. H787CT80STPD0 15051684018036

    Patients

    Seq Age Sex Outcome Treatment
    1