BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 22574109 · Received July 23, 2025

    Report

    Report Number
    3014312726-2025-00166
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 13, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMI
    UDI-DI
    10884521544628
    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

    TESTS PERFORMED ON THE RECEIVED SAMPLES OF MONOJECT HYPODERMIC SAFETY NEEDLE REF 1182110, LOT 02305014 CONFIRMED THAT THE DEVICES ARE SUITABLE FOR USE. ALL COMPONENTS WERE PRESENT AND PROPERLY ASSEMBLED. THE NEEDLE/SYRINGE COMBINATIONS (BOTH LUER LOCK AND LUER SLIP) WERE FOUND TO BE COMPLIANT WITH ISO 80369-7, AND NO LIQUID LEAKAGE WAS DETECTED DURING SIMULATION TESTING. UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE OF QUALITY ISSUES ASSOCIATED WITH THIS COMPLAINT BASED ON THE ARCHIVE SAMPLE ANALYSIS. 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. ADDITIONAL ASSESSMENT WILL BE TAKEN IF A SIGNIFICANT PATTERN EMERGES. UNCONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THIS NEEDLE LEAKING. WHEN THEIR LAB WAS DRAWING BLOOD, THE BLOOD STARTS RUNNING OUT THE SIDE OF THE NEEDLE DOWN THE PATIENT'S ARM. THE CUSTOMER ALSO STATED THAT THIS IS ALSO HAPPENING WITH MEDICATION BEING ADMINISTERED TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785353 MONOJECT MONOJECT HYPODERMIC SAFETY NEEDLE 21G*1 FMI SOL-MILLENNIUM MEDICAL INC 1182110 02305014 10884521544628

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown