BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDEN SHILEY ENDOTRACEAL TUBE

    MDR report key: 12814107 · Received November 12, 2021

    Report

    Report Number
    MW5105302
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDTRONIC (COVIDEN) / COVIDIEN
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A (B)(6) YEAR OLD MALE WITH HISTORY OF ALCOHOL ABUSE PRESENTED TO THE ED WITH HEMATEMESIS. IN THE ED, HE VOMITED 1 LITER OF BLOOD AND BECAME HYPOTENSIVE WITH A SBP OF 80. HE WAS INTUBATED FOR AIRWAY PROTECTION. THE BALLOON ON THE ENDOTRACHEAL TUBE WAS INFLATED BEFORE THE PROCEDURE WITHOUT AN ISSUE. A #8 ETT WAS PLACED USING A GLIDESCOPE. THE BALLOON FILLED AFTER INTUBATION. THE RESPIRATORY THERAPIST NOTED WITHIN 30 SECONDS THAT THE BALLOON HAD DEFLATED. ATTEMPTED TO RE-INFLATE TIMES 3 BUT DEFLATED EACH TIME. THE ETT WAS REMOVED AND A NEW TUBE WAS INSERTED. THE PATIENT DID NOT SUSTAIN AN INJURY. WE CURRENTLY HAVE THE TUBE AND PACKAGING. WE WILL PROVIDE IT TO THE MANUFACTURER IF THEY WOULD LIKE TO HAVE IT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699831 COVIDEN SHILEY ENDOTRACEAL TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO MEDTRONIC (COVIDEN) / COVIDIEN 21A0299JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention