BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE

    MDR report key: 8530174 · Received April 18, 2019

    Report

    Report Number
    3012307300-2019-02111
    Event Type
    Injury
    Date Received
    April 18, 2019
    Report Date
    May 15, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A DUPLICATE INCIDENT TO THE SUBMISSION FILE NUMBER 3012307300-2018-03306, SENT ON 08-24-2018. THIS WAS NOTED TO BE A DUPLICATE SUBMISSION FILE ON 05-14-2019.

    Description of Event or Problem · 0

    THIS REPORT IS A DUPLICATE INCIDENT TO THE SUBMISSION FILE NUMBER 3012307300-2018-03306, SENT ON 08-24-2018. THIS WAS NOTED TO BE A DUPLICATION SUBMISSION ON 05-14-2019.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS IN USE, IT HAD SLIPPED OUT OF THE HOLDER AND PATIENT WAS EXTUBATED. SOME PATIENTS THEN REQUIRED REINTUBATION AND RESUSCITATION DUE TO COMPROMISED AIRWAY. THERE WAS NO SPECIFICITY ON THE NUMBER OF PATIENTS THIS OCCURRED WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319139 SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) CBI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R