BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3890002 · Received June 12, 2014

    Report

    Report Number
    3890002
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 12, 2014
    Manufacturer
    KIMBERLY CLARK CORP.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE BROKE ON INSERTION - ALL PARTS WERE RECOVERED, AND THERE WAS NO PATIENT HARM.======================MANUFACTURER RESPONSE FOR SUBGLOTTIC SUCTIONING ET TUBE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================ACKNOWLEDGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348689 * TUBE, TRACHEAL (W/WO CONNECTOR) BTR KIMBERLY CLARK CORP. 1322000 AA3227V01

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR DURING SURGERY