BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONESTEP

    MDR report key: 24550807 · Received March 9, 2026

    Report

    Report Number
    1721504-2026-00905
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    October 31, 2025
    Report Date
    March 9, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    OJV
    UDI-DI
    00884450038710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    ACCOUNT REPORTED THE ONE-STEP 5 FRENCH 7C 8MM CATHETER WAS BEING USED DURING A RADIOLOGICAL PROCEDURE. THE PROVIDER NOTED THAT THE CATHETER WAS NOT DRAINING DURING A ROUTINE THERAPEUTIC PARACENTESIS. THE DOCTOR REMOVED THE CATHETER AND DISCOVERED THAT THE TIP OF THE CATHETER WAS NO LONGER PRESENT. ULTRASOUND SHOWED THAT THE TIP WAS RETAINED AND PRESENT IN THE SUBCUTANEOUS TISSUE OF THE RIGHT LOWER QUADRANT OF THE ABDOMEN. SURGERY WAS CONSULTED AND SCHEDULED. UNFORTUNATELY, NEITHER THE PACKAGING OR THE CATHETER ITSELF WAS SAVED BY THE DIAGNOSTIC RADIOLOGY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610935 ONESTEP SINGLE USE INSTRUMENT TRAY OJV MERIT MEDICAL SYSTEMS, INC. 00884450038710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention