BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 10042514 · Received May 11, 2020

    Report

    Report Number
    10042514
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 6, 2020
    Manufacturer
    COOK MEDICAL, LLC
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT TO IRL FOR ULTRASOUND GUIDED THORACENTESIS. DOCTOR LOCATED THE PLEURAL EFFUSION USING ULTRASOUND GUIDANCE. STANDARD PROCEDURE WAS PERFORMED. YUEH CENTESIS CATHETER WAS PLACED WITHIN THE PLEURAL SPACE, AFTER REMOVAL OF THE CATHETER, DISTAL TIP WAS MISSING (5-9 MM). CATHETER WAS REMOVED WITHOUT RESISTANCE. A CT OF THE CHEST WAS PERFORMED IMMEDIATELY TO VISUALIZE THE TIP. CT DEMONSTRATED CATHETER TIP FRAGMENT WITHIN SUBCUTANEOUS FAT 1.1 CM DEEP TO THE SKIN SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508699 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE NEEDLE, CATHETER GCB COOK MEDICAL, LLC 13017815

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA