BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035693 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00015
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    January 24, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    GAA
    UDI-DI
    00818392015294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 01/30/2025. 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. SCAR 20241001 WAS INITIATED AT THE MANUFACTURING SITE TO TRACK THE INVESTIGATION AND APPLICATION OF CORRECTIVE ACTIONS ASSOCIATED WITH THE EVENT. CORRECTIVE ACTIONS INCLUDE OPTIMIZATION OF SANDBLASTING PROCESS AND EQUIPMENT, INCREASE INSPECTION SAMPLING FREQUENCY, AND UPDATE ENGINEERING DRAWINGS TO CLARIFY SANDBLASTING REQUIREMENTS. CORRECTIVE ACTIONS WERE VERIFIED BY INSPECTION OF 3 BATCHS PRODUCED AFTER IMPROVEMENT IMPLEMENTATION. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE MANUFACTURING SITE INFORMATION PROVIDED IN THE INITIAL MDR [3014312726-2025-00015]. THE PREVIOUSLY REPORTED SITE WAS INCORRECT. THE CORRECT MANUFACTURING SITE IS: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. NO. 758, 5TH BINHAI ROAD BINHAI INDUSTRIAL PARK LONGWAN, WENZHOU, ZHEJIANG PROVINCE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT NUMBER: (B)(4). CUSTOMER REPORTED THAT THE RUBBER PARTICLES INSIDE MEDICINE VIALS AND SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118358 SOL-MILLENNIUM SOL-M BLUNT FILL NEEDLE 18G*1 1/2" GAA SOL-MILLENNIUM MEDICAL INC 110022 02401091 00818392015294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown