BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN IVSTAR

    MDR report key: 23154364 · Received September 26, 2025

    Report

    Report Number
    23154364
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 18, 2025
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NURSES REPORTED SEVERAL PATIENTS WITH PARENTERAL NUTRITION LEAKING AT OR AROUND THE 1.2 MICRON LIPID FILTER IN THE IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112853 CODAN IVSTAR SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 250424-00008858

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male