BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035667 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00273
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    June 28, 2024
    Report Date
    August 12, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    GAA
    UDI-DI
    50351688080385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANOMALIES WERE FOUND ON ARCHIVED SMITHS MEDICAL BLUNT FILL NEEDLE W/FILTER 18G*1 1/2"REF BN1815F LOT 221215 CHECKED. ALL VALUES OBTAINED FROM THE TEST ON ARCHIVE SAMPLES DEMONSTRATE THE QUALITY OF THE PRODUCT, HOWEVER, BASED ON CUSTOMER STATEMENT AND RECEIVED PHOTO, WE CONFIRM THE ISSUE. IN THIS CASE AN ISOLATED ACCIDENTALLY PRODUCTION ISSUE HAS GENERATED THE DEFECTIVE PIECE: NEEDLE HUB AND CONNECTER WERE WELDED BY AUTOMATIC ULTRASONIC WELDING MACHINE, BUT DUE TO SUDDEN STOP OF THE ASSEMBLY LINE, INVOLVED PIECE DID NOT COMPLETE WELDING PROCESS, REMAINING ON THE ASSEMBLY LINE, WITHOUT THE OPERATOR BEING ABLE TO DETECT IT BECAUSE IT IS SLIGHTLY WELDED. TO CONTAIN THE ISSUE, MANUFACTURER PARTNER HAS ISSUED A NEW VERSION OF OPERATIONAL PROCEDURE RELATED TO THIS PARTICULAR PRODUCTION MOMENT. ALL THE INVOLVED PERSONNEL WERE RETRAINED BASED ON THE NEW CONTENT OF THE PROCEDURE. SOL-MILLENNIUM WILL CONTINUE TO MONITOR THIS TYPE OF ISSUE AND IF DATA WILL INCREASE, FURTHER EVALUATION WILL BE PERFORMED. THIS REPORT WAS INITIALLY SUBMITTED ON 07/12/2024. 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: PREPARING PATIENT ANTIBIOTICS, I HAD DRAWN UP THE FLUID REQUIRED AND INJECTED IT INTO THE MEDICATION BOTTLE. AFTER MIXING I WITHDREW THE FLUID FROM THE BOTTLE INTO A SYRINGE. AS I WAS INJECTING THE MIXED FLUID INTO A 100ML SALINE BAG FOR ADMINISTRATION THE NEEDLE BROKE AT THE CASING CAUSING SOME FLUID TO BE SQUIRTED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217126 SOL-MILLENNIUM SMITHS MEDICAL BLUNT FILL NEEDLE W/FILTER 18G*1 1/2" GAA SOL-MILLENNIUM MEDICAL INC BN1815F 221215 50351688080385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown