BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/CF TRACHEAL TUBE

    MDR report key: 3131246 · Received May 23, 2013

    Report

    Report Number
    3003898360-2013-00212
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 8, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS CONDUCTED FROM A PHOTO PROVIDED BY THE DISTRIBUTOR. FROM THE PHOTO IT WAS OBSERVED IMPROPER PACKAGE INDICATION. NO OTHER DEFECTS WERE OBSERVED. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD (DHR) WAS CONDUCTED ON THE REPORTED LOT NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. ASSESSMENT REVIEW OF FMEA (PRODUCT/PROCESS) WAS CONDUCTED AND NO CHANGES REQUIRED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION TAKEN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: AN IMPROPER PACKAGE INDICATION WAS DETECTED DURING INCOMING INSPECTION BY THE DISTRIBUTOR. NO PT INJURY/INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228677 HUDSON SHERIDAN/CF TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01G1200060

    Patients

    Seq Age Sex Outcome Treatment
    1