BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO PUNCTURE SET

    MDR report key: 24213485 · Received January 29, 2026

    Report

    Report Number
    MW5183065
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 23, 2026
    Manufacturer
    TELEFLEX / TELEFLEX LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CARDIOLOGIST USED ULTRASOUND GUIDED ACCESS FOR THE RIGHT INTERNAL JUGULAR VEIN DURING SHEATH PLACEMENT FOR A RIGHT-HEART CATHETERIZATION. AFTER VERIFYING VIA ULTRASOUND AND X-RAY THAT THE WIRE USED FOR ACCESS WAS NOT IN THE RIGHT INTERNAL JUGULAR VEIN, THE CARDIOLOGIST ATTEMPTED TO REMOVE THE WIRE AND REDIRECT IT. UPON ATTEMPTED REMOVAL OF THE WIRE, THE RADIOPAQUE TIP SHEARED OFF THE WIRE AND REMAINED IN THE PATIENT'S NECK. ULTRASOUND AND X-RAY WERE USED TO CONFIRM THAT THE WIRE WAS NOT MOBILE AND WAS MAINTAINED WITHIN THE PATIENT'S TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268569 MICRO PUNCTURE SET INTRODUCER, CATHETER DYB TELEFLEX / TELEFLEX LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other