BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035768 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00060
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    March 4, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    MEG
    UDI-DI
    00818392017267
    PMA / PMN Number
    K162030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 03/18/2025. 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. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT ALL MANUFACTURER CONTACT OFFICE INFORMATION AND DATE OF EVENT, PRODUCT DESCRIPTION AND UDI PROVIDED IN THE INITIAL MDR [3014312726-2025-00060. THE PREVIOUSLY REPORTED WAS INCORRECT. THE CORRECT MANUFACTURE CONTACT INFORMATION IS BELOW; (B)(4), QA ENGINEER, SOL-MILLENNIUM MEDICAL INC, 311 S. WACKER DR., SUITE 4100, CHICAGO, IL 60606, UNITED STATES, (B)(4). THE CORRECT DATE OF EVENT IS 04-MARCH-2025. THE CORRECT PRODUCT DESCRIPTION IS SOL-CARE SAFETY BLOOD COLLECTION NEEDLE 21G 3/4 12INCH (WITHOUT NON-PATIENT NEEDLE CAP). THE CORRECT PRODUCT UDI IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PCA WAS ATTEMPTING VENI PUNCTURE BLOOD DRAW TO PATIENTS LEFT AC. AFTER RETRACTING NEEDLE INTO SAFETY PLASTIC TIPS, PLASTIC TIP PINCHED PATIENTS ARM AT INSERTION SITE. PLASTIC PIECE PINCHED PATIENT'S ARM. AFTER RETRACTING NEEDLE, THE PLASTIC PIECE WAS STUCK TO PATIENTS' ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118433 SOL-MILLENNIUM SOL-CARE SAFETY BLOOD COLLECTION NEEDLE 21G*3/4*12INCH MEG SOL-MILLENNIUM MEDICAL INC 110201030031 05104011 00818392017267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown