BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3042078 · Received April 3, 2013

    Report

    Report Number
    2936999-2013-00257
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED THAT A PT WAS INTUBATED BY AMBULANCE ATTENDEE ON (B)(6) 2013. CALLER REPORTED THAT THE ETT WAS CHANGED TO THE TAPERGUARD ETT ON (B)(6) 2013, AND ON (B)(6) 2013, THE NURSE REMOVED SOME TAPE THAT WAS SECURING THE ETT AND THE TUBE AND THE PILOT BALLOON OF THE TAPERGUARD FELL OFF AND THE CUFF LEAKED/DEFLATED AND THE PT COULD NOT BE VENTILATED. THE PILOT BALLOON WAS DISCARDED SO CANNOT BE RETURNED FOR INSPECTION. CUSTOMER STATED THAT PT WAS RE-INTUBATED AS AN EMERGENCY DIFFICULT INTUBATION WITH A BOUGIE BY THE CONSULTANT INTENSIVIST AND PUT BACK ON THE VENTILATOR. CUSTOMER CONFIRMED THE PT WAS VENTILATED AGAIN. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137352 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention