BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035942 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00069
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    March 24, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMI
    UDI-DI
    00818392016093
    PMA / PMN Number
    K123684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED ON 03/25/2025. DUE TO ISSUES WITH DISPLAYING THE INITIAL SUBMISSION, THIS SUBMISSION CONTAINS BOTH INITIAL AND SUPPLEMENTAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT WHEN INITIALLY SUBMITTED ENCOUNTERED AN INTERNAL ISSUE POTENTIALLY RELATED TO DATABASE CONNECTIVITY. THIS ISSUE WAS IDENTIFIED WHILE IMPLEMENTING CAPA-57 WHICH WAS OPENED FOLLOWING AN FDA INSPECTION. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO REMOVE THE CHN FROM MANUFACTURER SITE AND CORRECT ALL MANUFACTURER CONTACT OFFICE INFORMATION PROVIDED IN THE INITIAL MDR [3014312726-2025-00069]. THE PREVIOUSLY REPORTED WAS INCORRECT. THE CORRECT MANUFACTURE CONTACT INFORMATION IS BELOW; (B)(4), QA ENGINEER, SOL-MILLENNIUM MEDICAL INC, 311 S. WACKER DR., SUITE 4100, CHICAGO, IL 60606, UNITED STATES, (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT PARTS OF RUBBER MEMBRANE WAS DISCOVERED IN THE SYRINGE WHEN THEY HAD RETRIEVED THE LIQUID FROM THE GLASS BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749496 SOL-MILLENNIUM NEEDLE HYPODERMIC 18G 50MM FMI SOL-MILLENNIUM MEDICAL INC 111820 UNKNOWN 00818392016093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown