BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22156681 · Received June 6, 2025

    Report

    Report Number
    3014312726-2025-00125
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 18, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMF
    UDI-DI
    00840368503153
    PMA / PMN Number
    K153537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE MANUFACTURING SITE INFORMATION PROVIDED IN THE INITIAL MDR 3014312726-2025-00125. THE PREVIOUSLY REPORTED MANUFACTURING SITE WAS INCORRECT. THE CORRECT MANUFACTURING SITE IS: PROMISEMED HANGZHOU MEDITECH CO.,LTD.

    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. ALL THE RETAINED SAMPLES AND CUSTOMER SAMPLES TESTED WERE WITHIN PRODUCT SPECIFICATION REQUIREMENTS AND NO EVIDENCE OF QUALITY ISSUES ASSOCIATED WITH THIS COMPLAINT. AS PART OF OUR CONTINUED COMMITMENT TO OUR CUSTOMERS, SOL MILLENNIUM WILL CONTINUE TO MONITOR THE COMPLAINTS TREND FOR THE REPORTED FAILURE MODE AND TAKE ANY CORRECTIVE ACTION BASED ON OUR PROCEDURES, IF A SIGNIFICANT PATTERN EMERGES. UNCONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE PRODUCT LEAKAGE OF INSULIN SYRINGES AND ASK FOR RETURN GOODS OR RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462667 SOL-MILLENNIUM SOL-M 0.5ML INSULIN SYRINGE W/FIXED NEEDLE 31G*8MM FMF SOL-MILLENNIUM MEDICAL INC 1653151BKM 07311041 00840368503153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown