BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035731 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00038
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 28, 2026
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMF
    UDI-DI
    00818392015041
    PMA / PMN Number
    K092430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 THE 510K NUMBER PROVIDED IN THE INITIAL MDR [3014312726-2025-00038]. THE PREVIOUSLY REPORTED 510K NUMBER WAS INCORRECT. THE CORRECT 510K IS K092430.

    Additional Manufacturer Narrative · 0

    BASED ON THE DETERMINED RISK PRIORITY NUMBER, THE RESIDUAL RISK RELATED TO THIS COMPLAINT IS CONSIDERED ACCEPTABLE. HOWEVER, SOL MILLENNIUM DECIDED TO OPEN A SUPPLIER CORRECTIVE ACTION REQUEST TO THE SUPPLIER FOR FURTHER INVESTIGATION OF THE ISSUE. ALL ACTIONS WILL BE FOLLOWED IN THE SCAR NUMBER: 20250202. ONCE THE SCAR REPORT IS AVAILABLE A DETAILED CORRECTIVE ACTION WILL BE SHARED. THIS REPORT WAS INITIALLY SUBMITTED ON 02/20/2025. DUE TO ISSUES WITH DISPLAYING THE INITIAL SUBMISSION, THIS SUBMISSION CONTAINS BOTH INITIAL AND SUPPLEMENTAL INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE NEEDLE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473470 SOL-MILLENNIUM SOL-CARE 10ML LUER LOCK SAFETY SYRINGE W/EXCH NEEDLE 21G* FMF SOL-MILLENNIUM MEDICAL INC TW160072IMLD 04409110 00818392015041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown