BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOL-M

    MDR report key: 24980013 · Received April 24, 2026

    Report

    Report Number
    3014312726-2026-00032
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 23, 2026
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMF
    UDI-DI
    00810018095161
    PMA / PMN Number
    K101359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. AS PART OF OUR CONTINUOUS PROCESS IMPROVEMENT PLAN, A RANDOM SAMPLING STRATEGY WAS REINFORCED FOR 27 IDENTIFIED BATCH NUMBERS OF SYRINGE IN BULK STERILE, AND THE FINAL PRODUCT INSPECTION WAS UPGRADED. THE INSPECTION INVOLVED (B)(4) SAMPLES PER LOT (TOTAL (B)(4) PCS) AND CONFIRMED FULL COMPLIANCE WITH PRODUCT SPECIFICATIONS, WITH NO CRACKED SYRINGES DETECTED. 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE 10 ML SYRINGE FROM THE NASAL PACK CRACKED WHEN THE SURGEON WENT TO USE IT (MINIMAL PRESSURE APPLIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381439 SOL-M SOL-M 10ML LUER LOCK SYRINGE W/O NEEDLE FMF SOL-MILLENNIUM MEDICAL INC P180010BS 04505010 00810018095161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown