BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FLEXI-SLIP STYLET 14 FR, 45CM

    MDR report key: 2901540 · Received January 4, 2013

    Report

    Report Number
    8040412-2013-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    COMPLAINT IS REPORTED AS: THE STYLET WAS UNABLE TO BE REMOVED FROM THE ET TUBE DURING INTUBATION. COMPLAINT STATES THAT FORCE WAS REQUIRED TO REMOVE THE STYLET. THE PT WAS ALMOST EXTUBATED DURING REMOVAL OF THE STYLET. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4440 RUSCH FLEXI-SLIP STYLET 14 FR, 45CM FLEXI-SLIP STYLET BSR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1