BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ACCESS KIT

    MDR report key: 23064509 · Received September 16, 2025

    Report

    Report Number
    1721504-2025-00363
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    OEX
    UDI-DI
    00884450475645
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE AND DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT SCRATCHES ON THE CLEAR FILM OF THE PACKAGING WERE FOUND. NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561382 MINI ACCESS KIT ACCESS KIT OEX MERIT MEDICAL SYSTEMS, INC. 00884450475645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention