BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, UNCUFFED, 2.5MM

    MDR report key: 3851518 · Received March 25, 2014

    Report

    Report Number
    3003898360-2014-00196
    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 SAMPLES WERE RECEIVED BY THE MANUFACTURING BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. THE CUSTOMER RETURNED A TOTAL OF FIVE UNUSED SAMPLES. PER DHR (DEVICE HISTORY RECORD) THE PRODUCT ET TUBE, UNCUFFED, 2.5, LOT #01G1300290 WAS MANUFACTURED ON 07/25/2012. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. 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 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
    173929 HUDSON ET TUBE, UNCUFFED, 2.5MM ENDOTRACHEAL TUBE BTR TELEFLEX 01G1300290

    Patients

    Seq Age Sex Outcome Treatment
    1