BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-M

    MDR report key: 23766978 · Received December 10, 2025

    Report

    Report Number
    3014312726-2025-00208
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 10, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMI
    UDI-DI
    10612479244624
    PMA / PMN Number
    K123684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION, NO ABNORMALITIES OR DEVIATIONS WERE IDENTIFIED IN THE BATCH RECORDS OR ARCHIVED SAMPLES OF THE REPORTED LOT (CSOD12-05). ALL SAMPLES TESTED, INCLUDING VISUAL INSPECTION, SIMULATION OF USE, AND ISO 80369-7 PERFORMANCE TESTS, MET THE ACCEPTANCE CRITERIA.AS NO SAMPLE OR PICTURE WAS RECEIVED FROM THE CUSTOMER, THE REPORTED ISSUE COULD NOT BE DIRECTLY VERIFIED. BASED ON THE DETERMINED RISK PRIORITY NUMBER, THE RESIDUAL RISK RELATED TO THE COMPLAINT IS CONSIDERED ACCEPTABLE. ADDITIONALLY, NO TRENDS RELATED TO THIS ISSUE HAVE BEEN IDENTIFIED DURING OUR TRACK-AND-TREND ANALYSIS.SOL MILLENNIUM CONTINUES TO MONITOR THIS KIND OF ISSUE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE MEDICAL ASSISTANT DREW UP THE PENTACEL WITH THE 25G X5/8 IN SYRINGE WITH SAFETY HYPODERMIC NEEDLE 1CC AND THEN ATTACHED THE 25G X 1 INCH (MFR 16-N251S; LOT CSOD12-05) TO THE SYRINGE TO ADMINISTER THE VACCINE. WHEN GIVING THE VACCINE TO THE PATIENT THE NEEDLE BROKE OFF THE SYRINGE AND THE VACCINE SPILLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878141 SOL-M NEEDLE, SAFETY 25GX1" (HINGED STYLE) FMI SOL-MILLENNIUM MEDICAL INC 16-N251S CSOD12-05 10612479244624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown