BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-LINK

    MDR report key: 22069773 · Received May 22, 2025

    Report

    Report Number
    22069773
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    February 25, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IV EXTENSION TUBING LEAKED DURING CONTRAST ADMINISTRATION. CONSISTENT WITH 2 OTHER PATIENTS-LEAKING IN THE SAME SPOT IN THE TUBING WITH SAME LOT#. REPORTED TO THE COMPANY BAXTER. ASKED TO PLACE SAFER BY CORPORATE SUPPLY CHAIN VALUE & SAFETY CLINICAL COORDINATOR. MANUFACTURER RESPONSE FOR IV EXTENSION SET, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514525 ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 7N8301 R24K23086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown