BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, PREFORMED UNCUFFED NASAL, 5.0

    MDR report key: 4102002 · Received September 15, 2014

    Report

    Report Number
    3003898360-2014-00745
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND AN INCONSISTENT DESCRIPTION ON THE PRINTED SEALED PACKAGE OF THE PRODUCT CODE WAS OBSERVED, THE PART NUMBER AND THE LOT NUMBER MATCH THE WORK ORDER, BUT THE DESCRIPTION DOES NOT MATCH TO THE WORK ORDER , THE EXTERIOR CARTON LABELS AND THE INDIVIDUAL LABELS ARE ACCORDING TO THE PRODUCT CODE REQUIREMENTS. CUSTOMER COMPLAINT CAN BE CONFIRMED WITH LOT NUMBER REPORTED. UPON DHR REVIEW IT WAS OBSERVED THAT THE LOT AFFECTED WITH OUTER/INNER LABEL MISMATCH ISSUE. HOWEVER, TO CORRECT THIS SITUATION FOR SIMILAR COMPLAINTS RECEIVED, A CAPA REQUEST WAS ISSUED IN ORDER TO INVESTIGATE AND ADDRESS THIS ISSUE ON THE PROCESS. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PACKAGING STATES THE PRODUCT IS A PREFORMED CUFFED TRACHEAL TUBE, HOWEVER, THE ACTUAL PRODUCT IS NOT CUFFED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569032 HUDSON ET TUBE, PREFORMED UNCUFFED NASAL, 5.0 ENDOTRACHEALTUBE BTR TELEFLEX 01M1300076

    Patients

    Seq Age Sex Outcome Treatment
    1