BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035443 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00080
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    May 15, 2024
    Report Date
    August 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.
    Product Code
    FMF
    UDI-DI
    00810018098544
    PMA / PMN Number
    K241821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. SOL MILLENNIUM CONTINUES TO MONITOR THIS KIND OF ISSUE. ADDITIONAL ASSESSMENT WILL BE TAKEN IF A SIGNIFICANT PATTERN EMERGES. UNCONFIRMED. THIS REPORT WAS INITIALLY SUBMITTED ON 04/04/2025. 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. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT ALL MANUFACTURER CONTACT OFFICE INFORMATION AND DATE OF EVENT PROVIDED IN THE INITIAL MDR [3014312726-2025-00080]. THE PREVIOUSLY REPORTED WAS INCORRECT. THE CORRECT MANUFACTURE CONTACT INFORMATION IS BELOW. SOL-MILLENNIUM MEDICAL INC (B)(6). THE CORRECT DATE OF EVENT IS 15-MAY-2024. THE COMPLAINT HAS BEEN CONFIRMED BASED ON THE CUSTOMER PROVIDED PICTURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THERE IS A CRACK ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088990 SOL-MILLENNIUM SOL-CARE 10ML SLIP TIP SYRINGE W/SAFETY NEEDLE 21G*1 1/2'' FMF SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. TW102115SSA 04203054 00810018098544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown