BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035415 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00259
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    June 6, 2024
    Report Date
    August 12, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.
    Product Code
    FMF
    UDI-DI
    00818392018257
    PMA / PMN Number
    K222744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANOMALIES WERE FOUND ON ARCHIVED AND RECEIVED SAMPLES OF RECORD SOL-M 30ML LUER LOCK SYRINGE W/O NEEDLE REF P180030, LOT 04203037 CHECKED. ROOT CAUSE BASED ON CUSTOMER STATEMENT, THE FACTORY THOUGHT IT MAYBE THAT INDIVIDUAL ASSEMBLY PERSONNEL DID NOT WEAR THE PROTECTIVE CLOTHING AND HATS SO GOOD, AND THE HAIR FELL OFF AND ADHERED TO THE INSIDE OF THE PRODUCT. CORRECTIVE ACTIONS 1. RETRAIN AND EDUCATE THE ASSEMBLY OPERATORS, REQUIRING ALL OPERATORS TO WEAR THE PROTECTIVE CLOTHING AND HATS WELL IN THE DESIGNATED CLOAKROOM BEFORE ENTERING THE WORK AREA; AT THE SAME TIME, THE PURIFICATION OPERATORS SHALL REGULARLY CLEAN THE WORKSHOP FLOOR AND CLEAN THE WORK-DESK, CLEAN THE HAIR IF FOUND THE HAIR FALL OFF, AND AVOID TO TAKING IT INTO THE PRODUCT. 2. RETRAIN AND EDUCATE ALL INSPECTORS, REQUIRED TO CHECK EACH PRODUCT ONE BY ONE, FOCUSING ON THE HAIR AND FOREIGN MATTER IN THE PRODUCT, AND ISOLATING AND SCRAPPING DEFECTIVE PRODUCTS IN TIME. 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 06/17/2024. 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: "IN OUR NICU THEY WERE OPENING A 30CC LUER LOCK SYRINGE AND FOUND A STRAND OF HAIR INSIDE THE PACKAGING. THIS THEN TRIGGERED A STERILE INCIDENT REPORT WITH OUR QUALITY DEPARTMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088963 SOL-MILLENNIUM SOL-M 30ML LUER LOCK SYRINGE W/O NEEDLE FMF SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. P180030 04203037 00818392018257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown