BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035736 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00102
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 16, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMF
    UDI-DI
    00810018095239
    PMA / PMN Number
    K101359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR EVALUATION OF THE RISK, WHICH FOLLOWS GUIDANCE FROM ISO 14971, INDICATES THAT THE OVERALL RISK FOR THE REPORTED FAILURE IS LOW. THIS EVALUATION IS BASED ON OUR TRACK AND TREND ANALYSIS AND RISK MANAGEMENT FILES WHICH ARE EVALUATED AND UPDATED CONSTANTLY BASED ON POST MARKET SURVEILLANCE. HOWEVER, SOL MILLENNIUM DECIDED TO OPEN A SUPPLIER CORRECTIVE ACTION REQUEST TO THE SUPPLIER FOR FURTHER INVESTIGATION OF THE ISSUE. ALL ACTIONS WILL BE FOLLOWED IN THE SCAR NUMBER: 20250301. ONCE THE SCAR REPORT IS AVAILABLE A DETAILED CORRECTIVE ACTION WILL BE SHARED. THIS REPORT WAS INITIALLY SUBMITTED ON 04/16/2025. 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; (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 SOMETHING RED WAS FOUND INSIDE THE (SECOND) 60ML SYRINGE. THE SYRINGES WERE CLEAN, AND ANESTHETIC HAD BEEN DRAWN. THE RED SUBSTANCE WAS NOTICED IN THE OPERATING ROOM BEFORE DRAWING THE ANESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118401 SOL-MILLENNIUM SOL-M 60ML LUER LOCK SYRINGE W/O NEEDLE (BULK, STERILE) FMF SOL-MILLENNIUM MEDICAL INC P180060BS 04405022 00810018095239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown