BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY KIT WITHOUT FORCEPS, 8.0MM - 100/543/0

    MDR report key: 8040291 · Received November 5, 2018

    Report

    Report Number
    3012307300-2018-08075
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    September 20, 2018
    Report Date
    November 5, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY'S CUFF WOULD NOT INFLATE, AND CUSTOMER WAS UNABLE TO ACTIVATE THE SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880348 BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY KIT WITHOUT FORCEPS, 8.0MM - 100/543/0 TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3361642

    Patients

    Seq Age Sex Outcome Treatment
    1