BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035538 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00208
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 5, 2024
    Report Date
    August 13, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    00818392010497
    PMA / PMN Number
    K123684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 04/29/2024. 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.

    Description of Event or Problem · 0

    "CUSTOMER REPORTED: SOL-CARE SAFETY NEEDLE LDS REF SN2510 25 GAUGE 1-INCH FROM SOL-MILENNIUM MEDICAL INC. USED TO RE-CONSTITUTE INFANRIX-HEXA (DTAP-IPV-HIB-HB) PRODUCT PRIOR TO VACCINE ADMINISTRATION. UPON PULLING THE NEEDLE OUT OF THE VIAL, THE NEEDLE BROKE OFF FROM THE HUB AND APPEARED BENT. INSPECTION OF THE NEEDLE PRIOR TO RECONSTITUTION INDICATED NO CONCERNS WITH NEEDLE INTEGRITY. THE VACCINE WAS WASTED DUE TO SAME AND A NEW NEEDLE FROM A DIFFERENT MANUFACTURER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216092 SOL-MILLENNIUM SOL-CARE SAFETY NEEDLE 25G*1" FMI SOL-MILLENNIUM MEDICAL INC. SN2510 07110007 00818392010497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown