BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE, SPIRAL-FLEX, CUFFED, 6.0MM

    MDR report key: 2061481 · Received March 15, 2011

    Report

    Report Number
    3003898360-2011-00125
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    September 16, 2010
    Report Date
    February 2, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, 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

    THE EVENT IS REPORTED AS: THE PACKAGE WAS FOUND TORN/BROKEN DURING INCOMING INSPECTION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE, SPIRAL-FLEX, CUFFED, 6.0MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA 01D1000086

    Patients

    Seq Age Sex Outcome Treatment
    1