BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 17245843 · Received July 3, 2023

    Report

    Report Number
    17245843
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    February 15, 2023
    Report Date
    June 22, 2023
    Manufacturer
    TELEFLEX LLC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: ANESTHESIA DOCUMENTED ETT CUFF FAILURES DURING AN EMERGENCY INTUBATION BACKGROUND: 7.5 ETT CUFF FAILURE REPORTED AFTER PRE-CHECK VERIFICATION PERFORMED, GLIDESCOPE 3 IN USE ASSESSMENT: CONCERN FOR PRODUCT FAILURE, UNCLEAR IF PRODUCT PACKAGING WAS SAVED RECOMMENDATIONS: REFER TO SUPPLY CHAIN AND TRACK AND TREND. THE ISSUE WAS DESCRIBED AS TOTAL CUFF FAILURE THAT WAS EVIDENT IMMEDIATELY FOLLOWING INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253654 HUDSON RCI TUBE, TRACHEAL (W/WO CONNECTOR) BTR TELEFLEX LLC 73E2200155

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown