BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 12005881 · Received June 15, 2021

    Report

    Report Number
    2936999-2021-00567
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    January 22, 2019
    Report Date
    June 15, 2021
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTR
    UDI-DI
    10884522007627
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: A CASE OF THORACIC PNEUMATOSIS DUE TO SEVERE COUGHS AND TRACHEAL TUBE DISPLACEMENT INDUCED BY TRACHEAL TUBE SIZE MISMATCH SOURCE: JA CLINICAL REPORTS, (2019) 5:8 HTTPS://DOI.ORG/10.1186/S40981-019-0227-0. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF CLINICAL REPORTS, THE PATIENT WITH CHRONIC HEART FAILURE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) DUE TO RESPIRATORY FAILURE. IMMEDIATELY BEFORE ADMISSION, THE PATIENT'S AIRWAY WAS STABILIZED USING A CUFFED 8.5MM TRACHEAL TUBE. THE AIR LEAKAGE DID NOT STOP WITH THE REGULAR INTRACUFF PRESSURE (25CM H2O) DUE TO THE TRACHEAL TUBE MISMATCH. THE DIAMETER OF THE PATIENT'S TRACHEA WAS TOO LARGE FOR THE TUBE USED- A DIAMETER OF 28.6MM. A HIGHER INTRACUFF PRESSURE OF 35CM H2O WAS APPLIED TO PREVENT AIR LEAKAGE AND TRACHEAL TUBE MOVEMENT. THREE DAYS AFTER ADMISSION, A CHEST X-RAY SHOWED A MEDIAL STRIPE SIGN AND BASILAR HYPERLUCENCY INDICATING PNEUMOMEDIASTINUM AND PNEUMOTHORAX. PATIENT'S AIRWAY WAS CONVERTED TO PERCUTANEOUS TRACHEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893799 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR MMJ SA DE CV (USD) 18785 10884522007627

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention