BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035766 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00071
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    March 28, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    MEG
    PMA / PMN Number
    K092430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED ON 03/28/2025. 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 CORRECT ALL MANUFACTURER CONTACT OFFICE INFORMATION PROVIDED IN THE INITIAL MDR [3014312726-2025-00071]. THE PREVIOUSLY REPORTED WAS INCORRECT. THE CORRECT MANUFACTURE CONTACT INFORMATION IS BELOW. MOHANAPRIYA KANNUPAIYAN, QA ENGINEER, SOL-MILLENNIUM MEDICAL INC 311 S. WACKER DR., SUITE 4100 CHICAGO, IL 60606 UNITED STATES [email protected].

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THERE ARE PARTICULATE MATTERS FOUND INSIDE SYRINGE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118431 SOL-MILLENNIUM SOL-M LUER LOCK SYRINGE WITH EXCHANGEABLE NEEDLE 10ML 23G X MEG SOL-MILLENNIUM MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown