BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, UNCUFFED, 4.5

    MDR report key: 4142692 · Received September 24, 2014

    Report

    Report Number
    3003898360-2014-00737
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 2, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE PICTURE PROVIDED IT SEEMS TO BE A "IMPROPER PRODUCT INDICATION". 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 (DHR HISTORY RECORD) REVIEW THE PRODUCT ET TUBE, UNCUFFED, 4.5, LOT #01M1300065 WAS MANUFACTURED ON 12/12/2013. 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 A "IMPROPER PRODUCT INDICATION", COMPLAINT CANNOT BE CONFIRMED; HOWEVER, 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: THE DISTRIBUTOR REPORTS, DURING INCOMING INSPECTION, AN IMPROPER PRODUCT INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593777 HUDSON ET TUBE, UNCUFFED, 4.5 ENDOTRACHEAL TUBE BTR TELEFLEX 01M1300065

    Patients

    Seq Age Sex Outcome Treatment
    1