BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE

    MDR report key: 3063709 · Received April 12, 2013

    Report

    Report Number
    3003898360-2013-00154
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PED-SOFT ENDOTRACHEAL TUBE IS KINKING JUST PAST THE ADAPTOR ON THE PATIENT SIDE. THE NURSE ALSO MENTIONED THAT THE BLACK LINE, WHICH INDICATES THE BEVEL DIRECTION, IS NO LONGER ON THE PED-SOFT ENDOTRACHEAL TUBES. THE PATIENT WAS RE-INTUBATED. NO REPORT OF PATIENT INJURY OR DECREASE PULMONARY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158132 HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1