BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEDRAW¿

    MDR report key: 23854520 · Received December 19, 2025

    Report

    Report Number
    8020616-2025-00748
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MERIT MEDICAL SINGAPORE PTE LTD.
    Product Code
    DXN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE FAILURE AS REPORTED WAS OBSERVED AS THE SALINE WAS INTRODUCED INTO A RETURNED SAMPLE OF THE SYRINGE ASSEMBLY, A LEAK WAS FOUND ON THE SYRINGE ELBOW. THE CONDITION MAY BE CAUSED BY THE HANDLING OF THE SYRINGE DURING A BLOOD WITHDRAWAL PROCEDURE. TWISTING THE ELBOW TOO MUCH DURING SETUP OR WHILE PERFORMING A PROCEDURE MAY CAUSE IT TO SEPARATE OR CRACK. 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.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. NO LOT NUMBER WAS PROVIDED; THUS, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND A SEARCH OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING USE THE DEVICE LEAKED FROM THE ROOT OF THE ELBOW SYRINGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625391 SAFEDRAW¿ SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN MERIT MEDICAL SINGAPORE PTE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown