BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPORT CT/TI/POLY 8F

    MDR report key: 16364341 · Received February 10, 2023

    Report

    Report Number
    MW5114884
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 8, 2023
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LLD
    UDI-DI
    H787CT80STPA0
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 1:10 PM BY RISK, RDE - THIS PATIENT ENTERED THE OR (OPERATING ROOM) FOR PORT REMOVAL AND INSERTION OF A NEW PORT-A-CATH. UPON REMOVAL OF THE EXISTING PORT, PORT WAS INTACT AND CATHETER TIP WAS TORN UPON EXAMINATION. PORT AND CATHETER SAVED. PATIENT WAS TRANSFERRED TO AMARILLO FOR REMOVAL OF BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235640 SMARTPORT CT/TI/POLY 8F PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LLD ANGIODYNAMICS, INC. CT80STPA 5658362 H787CT80STPA0

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization