BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035487 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00095
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 8, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.
    Product Code
    GAA
    UDI-DI
    00818392015294
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 RETURN SAMPLE AND 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 04/09/2025. 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 PROVIDED IN THE INITIAL MDR [3014312726-2025-00095]. THE PREVIOUSLY REPORTED WAS INCORRECT. THE CORRECT MANUFACTURE CONTACT INFORMATION IS BELOW; (B)(4), QA ENGINEER, SOL-MILLENNIUM MEDICAL INC, 311 S. WACKER DR., SUITE 4100, CHICAGO, IL 60606, UNITED STATES (B)(4). THE CORRECT DATE OF EVENT IS (B)(6) 2025. THE COMPLAINT HAS BEEN CONFIRMED BASED ON THE CUSTOMER PROVIDED PICTURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT BLUNT NEEDLE LEADING TO CORING OF RUBBER TOP VIALS AS PICTURED IN THE ATTACHMENT. THE RUBBER DEBRIS AND COULD BE DRAWN UP INTO A SYRINGE AND ADMINISTERED TO A PATIENT. WE HAVE TESTED A NUMBER OF SOL-M NEEDLES ON DIFFERENT RUBBER TOP VIALS AND THEY HAVE CORE THE RUBBER EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089932 SOL-MILLENNIUM SOL-M BLUNT FILL NEEDLE 18G*1 1/2" GAA SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. 11022 02404030, 02410028, 05403025 00818392015294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown