BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3072546 · Received April 17, 2013

    Report

    Report Number
    2936999-2013-00297
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE - EVAL IN PROGRESS.

    Description of Event or Problem · 1

    THE CALLER, REP OF CLINIC DEPARTMENT, REPORTED THAT WHILE PREPARING TO INTUBATE A PT THE TOP CAP (CONNECTOR) BROKE OFF AND FELL ONTO THE FLOOR. THE CALLER REPORTED THAT ANOTHER TUBE DEMONSTRATED THE SAME ISSUE OF THE CAP BREAKING. THE CALLER CONFIRMED THAT NO INTERVENTION WAS REQUIRED AS THE PT HAD YET TO BE INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166660 MALLINCKRODT UNCUFFED, MURPHY TRACHEAL TUBE BTR COVIDIEN 111000619X

    Patients

    Seq Age Sex Outcome Treatment
    1