BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 18129958 · Received November 14, 2023

    Report

    Report Number
    18129958
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 1, 2023
    Manufacturer
    COOK INCORPORATED
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CAME DOWN FOR CT GUIDED THORACENTESIS. MD (MEDICAL DOCTOR) USED A 4FR 7CM YUEH TO ASPIRATE FLUID. FLUID WAS COLLECTED FOR CULTURE AND MD PULLED OUT THE YUEH. UPON PULLING IT OUT, ALL THAT CAME OUT WAS THE HUB OF THE CATHETER AND THE CATHETER ITSELF WAS LODGED IN THE PATIENT. FURTHER IMAGING WAS DONE IN AN ATTEMPT TO REMOVE CATHETER. GENERAL SURGERY CONTACTED AND ABLE TO PULL OUT CATHETER WITH A TEAM EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988737 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE NEEDLE, CATHETER GCB COOK INCORPORATED G09488 14864350

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Male