BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 8.0MM

    MDR report key: 3963669 · Received March 10, 2014

    Report

    Report Number
    3003898360-2014-00133
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    December 26, 2013
    Report Date
    February 13, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A DOCUMENT ASSESSMENT WAS CONDUCTED AND NO CHANGES WERE REQUIRED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT IT WAS DIFFICULT TO DEFLATE THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143805 HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 8.0MM ENDOTRACHEAL TUBE BTR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1