BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 10355951 · Received August 3, 2020

    Report

    Report Number
    2936999-2020-00552
    Event Type
    Death
    Date Received
    August 3, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 3, 2020
    Manufacturer
    COVIDIEN LP JUAREZ (MMJ)
    Product Code
    BTR
    UDI-DI
    30884522000479
    PMA / PMN Number
    K965132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE TUBE FROM CRASH CART WAS USED TO INTUBATE. CUFF DID NOT INFLATE AND AIRWAY WAS NOT EFFECTIVELY ESTABL ISHED. THE CUSTOMER STATED PATIENT WAS A COVID19 PATIENT. PATIENT CONTINUED TO CODE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819281 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR COVIDIEN LP JUAREZ (MMJ) 86451 30884522000479

    Patients

    Seq Age Sex Outcome Treatment
    1 Death