BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, CUFFED, SPIRAL -FLEX 7.5

    MDR report key: 3896461 · Received May 16, 2014

    Report

    Report Number
    3003898360-2014-00329
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 1, 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, IT WAS OBSERVED "DEFORMED". 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. PER DHR (DEVICE HISTORY RECORD) THE PRODUCT ET TUBE, CUFFED, SPIRAL-FLEX 7.5, LOT #01L1300254 WAS MANUFACTURED ON 11/21/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. FROM THE PICTURE IT WAS OBSERVED "DEFORMED", THE COMPLAINT CAN NOT BE CONFIRMED AND A CONCLUSIVE ROOT CAUSE CAN NOT BE DETERMINED SINCE THE SAMPLE WAS NOT AVAILABLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE IS DEFORMED. THE ALLEGED ISSUE WAS DETECTED DURING INCOMING INSPECTION BY DISTRIBUTOR ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294537 HUDSON ET TUBE, CUFFED, SPIRAL -FLEX 7.5 ENDOTRACHEAL TUBE BTR TELEFLEX 01L1300254

    Patients

    Seq Age Sex Outcome Treatment
    1