BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM 6.5 U/C STANDARD TRACHEOSTOMY TUBE

    MDR report key: 9211176 · Received October 18, 2019

    Report

    Report Number
    3012307300-2019-05611
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 18, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    10351688846914
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL (B)(6) CUSTOM 6.5 U/C STANDARD TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THE HOSPITAL. THE REPORTER STATED THE DEVICE "APPEARED TO BE MOLDY". SUBSEQUENTLY, A TUBE CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005251 BIVONA CUSTOM 6.5 U/C STANDARD TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. SU14KN65NSC013S 10351688846914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention