BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART PORT CT

    MDR report key: 24817763 · Received April 8, 2026

    Report

    Report Number
    1319211-2026-00096
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    June 21, 2023
    Report Date
    April 29, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    UDI-DI
    15051684018005
    PMA / PMN Number
    K062414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    PRIOR TO 2021, PLAINTIFF WAS DIAGNOSED WITH MYELODYSPLASTIC SYNDROME, A FORM OF BLOOD CANCER. THE TREATMENT FOR PLAINTIFFS' CANCER INCLUDED CHEMOTHERAPY. IN ORDER TO ADMINISTER THE CHEMOTHERAPY MEDICATIONS TO PLAINTIFF, HER PHYSICIANS HAD A PORT-A-CATHETER PLACED IN HER. ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF THE FOLLOWING: ANGIODYNAMICS' "SMARTPORT", IDENTIFIED BY THE FOLLOWING: MODEL NUMBER: CT75STSD, LOT NUMBER: 5723799, MANUFACTURER: ANGIODYNAMICS, INC. 26 FOREST STREET, MARLBOROUGH, MA 01752, FOR THE PURPOSES OF PLAINTIFFS CHEMOTHERAPY AT (B)(6). SUBSEQUENT TO THE PLACEMENT OF THE AFOREMENTIONED SMARTPORT, THE PLAINTIFF WAS CAUSED TO DEVELOP AN INFECTION, IDENTIFIED AS BACTEREMIA / SEPSIS, WHICH UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. THE PLAINTIFF UNDERWENT MEDICAL TREATMENT FOR THE INFECTION. AS PART OF THIS MEDICAL TREATMENT FOR THE INFECTION, PLAINTIFF WAS ADMITTED TO (B)(6) FOR MEDICAL SCIENCES CENTER ON OR ABOUT (B)(6) 2023, FOR TREATMENT OF BACTEREMIA/SEPSIS WHICH, UPON INFORMATION AND BELIEF, WAS CAUSED BY THE PORT CATHETER DEVICE. AS FURTHER TREATMENT FOR THE INFECTIONS, ON OR ABOUT (B)(6) 2023, THE PORT CATHETER WAS REMOVED ENTIRELY AT (B)(6) FOR MEDICAL SCIENCES CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90545 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC. H787CT75STSD0 5723799 15051684018005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H| L| O