BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE,CF,9.0MM

    MDR report key: 4142735 · Received September 24, 2014

    Report

    Report Number
    3003898360-2014-00736
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 3, 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

    FROM THE PICTURE PROVIDED IT SEEMS TO BE AN "IMPROPER PACKAGE SEALING". NO OTHER DEFECTS WERE OBSERVED. A FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD) THE PRODUCT ET TUBE, CF, 9.0, LOT #01L1300069 WAS MANUFACTURED ON 11/14/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. FROM THE PICTURE PROVIDED IT SEEMS TO BE AN "IMPROPER PACKAGE SEALING". HOWEVER, COMPLAINT CANNOT BE CONFIRMED; IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTIONS. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING INCOMING INSPECTION, BY THE DISTRIBUTOR (IMJ), AN IMPROPER PACKAGE SEAL WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593519 HUDSON ET TUBE,CF,9.0MM ENDOTRACHEAL TUBE BTR TELEFLEX 01L1300069

    Patients

    Seq Age Sex Outcome Treatment
    1