BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035617 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00003
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    January 7, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    QNQ
    UDI-DI
    00810018095116
    PMA / PMN Number
    K242291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED ON 01/13/2025. 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. 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. DUE TO UNAVAILABILITY OF BATCH NUMBER, THE INVESTIGATION COULDN'T BE ABLE TO CONCLUDE. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT PARTS OF RUBBER MEMBRANE WAS DISCOVERED IN THE SYRINGE WHEN THEY HAD RETRIEVED THE LIQUID FROM THE GLASS BOTTLE. THE CUSTOMER SAY THAT THIS HAPPENED A LOT LATELY, BUT THEY DO NOT KNOW HOW MANY TIMES AND THEY DO NOT HAVE LOT NUMBER. ISSUE WAS IDENTIFIED PRIOR TO USE AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217076 SOL-MILLENNIUM SOL-M 1ML SLIP TIP SYRINGE W/O NEEDLE QNQ SOL-MILLENNIUM MEDICAL INC P180011LDSBS UNKNOWN 00810018095116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown