BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035791 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00338
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    October 15, 2024
    Report Date
    August 11, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    JKA
    UDI-DI
    10304040063634
    PMA / PMN Number
    K163073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 10/22/2024. 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

    THE CUSTOMER REPORTS THAT THE SAFETY MECHANISM MALFUNCTIONED CAUSING A NEEDLESTICK INJURY. AS OF NOW, NO UDI#. A 62 YEAR OLD FEMALE WAS PERFORMING A HAND DRAW PROCEDURE WHEN THEY HAD RECEIVED A NEEDLESTICK INJURY. IT WAS A DIRTY STICK AS PATIENT HAD BEEN DRAWN. THE SITE AREA IS WASHED AND FOLLOWED UP WITH THE ER. FOLLOW SERIAL BLOOD DRAWS AT 6 WEEKS, 3 MONTHS, 6 MONTHS POST EXPOSURE. LNI FILED. ALL FOLLOW UP THROUGH OCCUPATIONAL HEALTH CLINICS. ONLY ONE REPORTED DEVICE INJURY AT THIS CLINIC FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328944 SOL-MILLENNIUM HENRY SCHEIN SAFETY BLOOD COLLECTION NEEDLE 23G*3/4*12INCH JKA SOL-MILLENNIUM MEDICAL INC 570-0734 05312006 10304040063634

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female