BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 12713052 · Received October 28, 2021

    Report

    Report Number
    3012307300-2021-10395
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 14, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15019517147735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. D5 IS THE PATIENT/CONSUMER., CORRECTED DATA: UPDATED (B1, B2, H1).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PHI INFORMATION: INITIALS (B)(6). DOB (B)(6) 2004. WEIGHT 71 LBS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE WAS INSERTED IN AUGUST AND WAS FINE AT FIRST BUT DEVELOPED A SLOW LEAK. THE VENT KEPT ALARMING FOR A LEAK FOR ABOUT A WEEK. AROUND THIS TIME, THE PATIENT STARTED TO EXPERIENCE BLEEDING AROUND THE TRACH AREA. PATIENTS MOTHER IS UNSURE IF THIS IS RELATED TO THE ISSUES BUT PATIENT IS STILL BLEEDING AND TWO MORE CUFFS EXPERIENCED PIN HOLE LEAKS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607876 BIVONA TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. HT18DS50NSB928N ST007725 15019517147735

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Unknown Required Intervention