BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035476 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00192
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    January 26, 2024
    Report Date
    August 13, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    QNQ
    UDI-DI
    00818392018165
    PMA / PMN Number
    K242291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 04/08/2024. 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.

    Description of Event or Problem · 0

    "CUSTOMER REPORTED: WE RECEIVED A COMPLAINT FROM RIVM FOR ITEM P180001PP WITH BATCH 04105025. IT HAD SEVERAL DEFECTS: SYRINGE WITHOUT GRADUATION MARKS: 1 PIECE. SYRINGE WITHOUT PLUNGER: 1 PIECE. CLOSED PACKAGING WITHOUT SYRINGE: 1 PIECE. SYRINGE EXPANDED AND WITH FISSURES; FRACTURE CRACKS: 3 PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132442 SOL-MILLENNIUM SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE QNQ SOL-MILLENNIUM MEDICAL INC. P180001PP 04105025 00818392018165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown