BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035609 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00272
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    June 26, 2024
    Report Date
    August 14, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMI
    UDI-DI
    00818392015102
    PMA / PMN Number
    K112777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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 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.

    Additional Manufacturer Narrative · 0

    (B)(4) 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.

    Description of Event or Problem · 0

    CUSTOMER SAYS: I AM SENDING YOU THIS EMAIL FOLLOWING TWO COMPLAINTS EVENTS AT THE (B)(6) HOSPITAL CENTER, ABOUT THE FOLLOWING DEVICE: HYPODERMIC NEEDLE 18G (1.2MM X 40MM). SOL - M. REF: (B)(4). LOT: 02310012. DDP: 15.10.2028. DDF: 11.2023. I WOULD LIKE TO SHIP OUT THE DEVICES FOR ANALYSIS IN ORDER TO DETERMINE IF THERE IS A DEFECT, CAUSING THE RUBBER CORING WITH THE ANTIBIOTIC BOTTLE. PLEASE NOTE THAT IT'S A RECURRING EVENT. YOU WILL FIND IN ATTACHED THE SCREENSHOT OF THE DECLARED ISSUE AS WELL AS THE PHOTOS OF THE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216163 SOL-MILLENNIUM SOL-M HYPODERMIC NEEDLE 18G*1 1/2" FMI SOL-MILLENNIUM MEDICAL INC 111815 02310012 00818392015102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown