BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE, 7.0MM

    MDR report key: 3193077 · Received June 21, 2013

    Report

    Report Number
    3003898360-2013-00277
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, 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) REVIEW THE PRODUCT ET TUBE, HVT, 7.0, LOT NUMBER: 01H1200038 WAS MANUFACTURED ON 08/15/2012. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT REVIEW (FMEA-PRODUCT/PROCESS) WAS CONDUCTED AND NO CHANGES REQUIRED. THE COMPLAINT CAN NOT 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 FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COMPLAINT RECEIVED VIA EMAIL FROM (B)(6). THE CUSTOMER ALLEGES THAT THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED AFTER INSERTION. THE ENDOTRACHEAL TUBE WAS REMOVED AND REPLACED WITH ANOTHER ET TUBE. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282965 HUDSON SHERIDAN/HVT TRACHEAL TUBE, 7.0MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01H1200038

    Patients

    Seq Age Sex Outcome Treatment
    1