BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-VANTAGE ADDAPTOR CONNECTOR

    MDR report key: 21890222 · Received April 23, 2025

    Report

    Report Number
    21890222
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 18, 2025
    Manufacturer
    WYETH PHARMACEUTICALS LLC
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN WENT TO HANG PIGGYBACK IV ANTIBIOTIC. WHEN SHE PULLED THE STOPPER FROM THE BOTTOM OF THE VIAL AND BEGAN TO MIX THE POWDERED MEDICATION INTO THE FLUID IN THE BAG, THE FLUID STARTED TO LEAK OUT FROM THE TOP AROUND THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272499 ADD-VANTAGE ADDAPTOR CONNECTOR SET, I.V. FLUID TRANSFER LHI WYETH PHARMACEUTICALS LLC 1141001 1018354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown