BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI LO TRACHEAL TUBE CUFFED / SHILEY HI LOW ORAL NASAL TUBE

    MDR report key: 10619910 · Received September 25, 2020

    Report

    Report Number
    10619910
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    September 5, 2020
    Report Date
    September 22, 2020
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FOUND DISCONNECTED FROM THE VENTILATOR. STAFF REPORTED ET TUBE WAS SLIPPING WHERE IT WAS CONNECTED TO THE VENTILATOR. THE CUFF WAS LEAKING. STAFF REPORTED RECOGNIZED THE PROBLEM IN ABOUT A MIN AND A HALF OR SO. THIS PT HAD AN ANOTHER VENTILATOR EVENT. SEE REPORT (B)(4). THERE WAS NOT A TEST TO CONFIRM THE IMPACT. WE WERE NOT ABLE TO DETERMINE WHAT BRAND OF ET TUBE THAT WAS IN THE PT. HOWEVER, WE NARROWED IT DOWN TO TWO POSSIBLE BRANDS: HI LO TRACHEAL TUBE 8.0 MM TUBE CUFFED MFR: (B)(4) MALLINKRODT COMPANY (B)(4) (YELLOW LOOKING PACKAGE); SHILEY HI-LO ORAL/NASAL TRACHEAL TUBE CUFFED REF 86113 8.0 MM I.D. 10.8 MM O.D., LOT 20B0632 JZX 2012 COVIDIEN MADE IN (B)(6). COVIDIEN LLC (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055216 HI LO TRACHEAL TUBE CUFFED / SHILEY HI LOW ORAL NASAL TUBE ET TUBE BTR

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other