BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-MILLENNIUM

    MDR report key: 22035645 · Received May 16, 2025

    Report

    Report Number
    3014312726-2024-00364
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    November 22, 2024
    Report Date
    August 11, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    QNQ
    UDI-DI
    20818392018169
    PMA / PMN Number
    K242291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 12/06/2024. 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 PT CAME FOR MODERNA COVID INJECTION TONIGHT. AS I WAS INJECTING THE VACCINE INTO THE PT., THE NEEDLE WAS IN THE PTS DELTOID MUSCLE CORRECTLY, WHEN I STARTED TO PRESS ON THE SYRINGE. THEN THE HUB OF THE SYRINGE SPRAYED OUTWARD THE VACCINE, SPRAYING THE PTS WIFE AND MYSELF. THE PT DID NOT GET THE VACCINE. THE NEEDLE POINT WAS REMOVED FROM THE PT., AND COTTON BALL APPLIED TO THE SITE. A SECOND SHOT WAS GIVEN TO THE PT., AS HE ACCEPTED THE SYRINGE WAS DEFECTIVE. PT DID NOT SUFFER ANY PAIN OR DISCOMFORT, ONLY THE FACT OF HAVING A SECOND COVID VACCINATION. THIS WAS FINE ACCORDING TO THE PT. AND CHARTED AS SUCH. ON INSPECTION AFTERWARDS, THE HUB OF THE 1 CC SINGLE USE SYRINGE HAD A CRACK IN IT AND WAS DEEMED DEFECTIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217104 SOL-MILLENNIUM SOL-M 1ML LUER LOCK SYRINGE W/O NEEDLE QNQ SOL-MILLENNIUM MEDICAL INC P180001PP 08104003 20818392018169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown