BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, CF, 4.5

    MDR report key: 3851533 · Received March 25, 2014

    Report

    Report Number
    3003898360-2014-00158
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 3, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 (FMEA) WAS CONDUCTED AND NO CHANGES REQUIRED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CUFF ON THE ENDOTRACHEAL TUBE IS INFLATING TO ODD SIZES. THE CUSTOMER ALLEGES THAT THE DEFECT CAUSED A TRACHEAL LACERATION IN A PET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173930 HUDSON ET TUBE, CF, 4.5 ENDOTRACHEAL BTR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1