BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, UNCUFFED, 2.5MM

    MDR report key: 3851511 · Received March 25, 2014

    Report

    Report Number
    3003898360-2014-00199
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. PER DHR (DEVICE HISTORY RECORD) THE PRODUCT ET TUBE, UNCUFFED, 2.5, LOT #01J1200471 WAS MANUFACTURED ON 10/04/2012. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT WAS CONDUCTED AND CHANGES WERE REQUIRED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE ENDOTRACHEAL TUBE HAS A VISIBLE INDENTION AT THE VERY TIP OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174231 HUDSON ET TUBE, UNCUFFED, 2.5MM ENDOTRACHEAL TUBE BTR TELEFLEX 01J1200471

    Patients

    Seq Age Sex Outcome Treatment
    1