BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, TRACHEOSTOMY (W/WO CONNECTOR), PRODUCT CODE: BTO

    MDR report key: 8974878 · Received September 9, 2019

    Report

    Report Number
    3012307300-2019-04407
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Report Date
    September 8, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE VOICEMAIL NOTIFICATION: THE CUSTOM TRACH WAS DEFECTIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION AS OF NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768236 TUBE, TRACHEOSTOMY (W/WO CONNECTOR), PRODUCT CODE: BTO BTO SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1