BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 22035498 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00199
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    March 22, 2024
    Report Date
    August 13, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    10884521544789
    PMA / PMN Number
    K123684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANOMALIES WERE FOUND ON THE ARCHIVED SAMPLES OF IMPACTED MONOJECT HYPODERMIC SAFETY NEEDLE 30G*1/2" REF 1183005, LOT 02204010 CHECKED. NO HOOK, BURRS OR OTHER CANNULA DEFECTS WERE FOUND, AND ALL ARCHIVED SAMPLES ARE WITHIN PRODUCT SPECIFICATION REQUIREMENTS FOR PENETRATION TEST PERFORMED IN ACCORDANCE WITH ISO 7864:2016 "STERILE HYPODERMIC NEEDLES FOR SINGLE USE" - ANNEX D "TEST METHOD FOR MEASURING THE PENETRATION FORCE AND DRAG FORCE FOR NEEDLES". IT IS UNKNOWN THE HANDLING OF THE PRODUCT BY THE END-USER. THIS REPORT WAS INITIALLY SUBMITTED ON 04/08/2024. 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 "REPORT TYPE (B1), OUTCOME ATTRIBUTED TO ADVERSE EVENT (B2) AND BRAND NAME (D1)" PROVIDED IN THE INITIAL MDR 3014312726-2024-00199. THE PREVIOUSLY REPORTED REPORT TYPE (B1) IS ADVERSE EVENT AND PRODUCT PROBLEM, OUTCOME ATTRIBUTED TO ADVERSE EVENT (B2) IS REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIREMENT, BRAND NAME (D1) IS SOL M WERE INCORRECT. THE CORRECT REPORT TYPE (B1) IS PRODUCT PROBLEM ONLY AND BRAND NAME (D1) IS MONOJET.

    Description of Event or Problem · 0

    "THE CUSTOMER REPORTED THAT PATIENTS WERE COMPLAINING OF PAIN WHEN INJECTING THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089943 MONOJECT MONOJECT HYPODERMIC SAFETY NEEDLE 30G*1/2" FMI SOL-MILLENNIUM MEDICAL INC. 1183005 02204010 10884521544789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention