BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEDRAW¿

    MDR report key: 23587252 · Received November 18, 2025

    Report

    Report Number
    1721504-2025-00615
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 2, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MERIT MEDICAL SINGAPORE PTE LTD.
    Product Code
    DXN
    PMA / PMN Number
    K935782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING USE THE DEVICE LEAKED FROM THE DEVICE. A NEW DEVICE WAS USED TO CONTINUE MONITORING THE PATIENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326381 SAFEDRAW¿ SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN MERIT MEDICAL SINGAPORE PTE LTD. C3207802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown