BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-M

    MDR report key: 25240025 · Received May 21, 2026

    Report

    Report Number
    3014312726-2026-00036
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 21, 2026
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMI
    UDI-DI
    00818392015157
    PMA / PMN Number
    K112777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PICTURES OF THE IMPACTED SOL-M HYPODERMIC NEEDLE 23G*1 1/4" (REF# 1123125, LOT# 02107115) WERE RECEIVED FROM THE CUSTOMER FOR EVALUATION. ALL ARCHIVED SAMPLES EVALUATED WERE COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS, INCLUDING SATISFACTORY PERFORMANCE IN STIFFNESS AND RESISTANCE TO BREAKAGE TESTING AS PER ISO 9626:2016. DUE TO THE ABSENCE OF RETURNED SAMPLES OR VISUAL EVIDENCE, THE EXACT CONTRIBUTING FACTORS ASSOCIATED WITH THE REPORTED ISSUE COULD NOT BE DETERMINED WITH CERTAINTY. THIS APPEARS TO BE AN ISOLATED INCIDENT WITH A VERY LOW COMPLAINT OCCURRENCE RATE. A REVIEW OF COMPLAINTS FROM THE PAST 12 MONTHS INDICATES THAT THIS IS THE ONLY COMPLAINT RECEIVED FOR SOL-M HYPODERMIC NEEDLE 23G*1 1/4" (REF: 1123125) RELATED TO BROKEN - CANNULA. OUR EVALUATION OF THE RISK, CONDUCTED IN ACCORDANCE WITH ISO 14971, INDICATES THAT THE OVERALL RESIDUAL RISK ASSOCIATED WITH THE REPORTED FAILURE MODE IS LOW AND ACCEPTABLE. THIS ASSESSMENT IS SUPPORTED BY TRACK-AND-TREND ANALYSIS AND RISK MANAGEMENT DOCUMENTATION, WHICH ARE CONTINUOUSLY REVIEWED AND UPDATED AS PART OF POST-MARKET SURVEILLANCE ACTIVITIES. AS PART OF OUR CONTINUED COMMITMENT TO PRODUCT QUALITY AND CUSTOMER SAFETY, SOL-MILLENNIUM WILL CONTINUE TO MONITOR COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND IMPLEMENT APPROPRIATE REINFORCEMENT OR PREVENTIVE MEASURES SHOULD A SIGNIFICANT TREND EMERGE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE HYPODERMIC SNAPPED OFF IN A PATIENT. CLEAN BREAK OFF AT EDGE OF BLUE LEUR LOCK CONNECTOR, COMPLETE NEEDLE RETRIEVED FORM PATIENT, WITH NO INCIDENT TO PATIENT". WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED DUE TO THE ISSUE? - NO WAS SURGERY OR THERAPY DELAYED WHILE THE PATIENT WAS UNDER ANESTHESIA? - NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409444 SOL-M SOL-M HYPODERMIC NEEDLE 23G*1 1/4" FMI SOL-MILLENNIUM MEDICAL INC 1123125 02107115 00818392015157

    Patients

    Seq Age Sex Outcome Treatment
    1