BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT

    MDR report key: 8375252 · Received February 27, 2019

    Report

    Report Number
    3012307300-2019-01048
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    January 1, 2019
    Report Date
    February 27, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY HAD A CANNULA CRACK, REQUIRING REPLACEMENT. THE INCIDENT WAS REPORTED AS BEING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169258 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT TRACHEOBRONCHIAL SUCTION CATHETER KIT OFR SMITHS MEDICAL ASD, INC. 3597096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention