BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL PORTEX LARYNGOTRACHEAL ANESTHESIA KIT

    MDR report key: 9327674 · Received November 15, 2019

    Report

    Report Number
    3012307300-2019-06242
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 31, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OGK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION WAS REPORTED STATING, " THEY NEED TO ANESTHETIZE THE PATIENT AND MOVE PATIENT TO ANOTHER HOSPITAL WHERE THEY COULD DO A BRONCHOSCOPY. " THIS INCIDENT IS LIFE THREATENING, AND THIS REPORTED INFORMATION IS CLASSIFIED AS MEDICAL INTERVENTION. B1: CORRECTED INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHILE SMITHS MEDICAL PORTEX LARYNGOTRACHEAL ANESTHESIA KIT WAS IN USE, THE CANNULA WAS NOTED TO BE CRACKED AND BROKEN WHILE INTUBATING THE PATIENT. WHILE USING A FIBERSCOPE TO PLACE ET TUBE, THE BROKEN TIP WAS IN THE LUNG. IT WAS ALSO REPORTED THAT THE DOCTOR INSTALLING THE LARYNGOTRACHEAL CANNULA TRIED TO BEND IT/SHAPE IT PRIOR TO USING. INCIDENT IS REPORTED TO BE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120241 SMITHS MEDICAL PORTEX LARYNGOTRACHEAL ANESTHESIA KIT OROTRACHEAL INTUBATION GUIDE KIT OGK SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R