BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ENDOTRACHEAL TUBE, CF, 8.0

    MDR report key: 4029933 · Received July 31, 2014

    Report

    Report Number
    3003898360-2014-00469
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 3, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. ONE UNIT OF CATALOG NUMBER 5-100116 (ET TUBE, CF, 8.0), LOT NUMBER 01A1400211, WAS FOUND THAT ALL COMPONENTS WERE ASSEMBLED PROPERLY. IT WAS ALSO OBSERVED THAT THE SEALED PACKAGE WAS IDENTIFIED AS PRODUCT CODE 5-10116 ET TUBE, CF, SIZE 8.0MM; HOWEVER, THE PRODUCT INSIDE WAS ACTUALLY A SIZE 7.5MM. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT WAS CONFIRMED. AS A CONTAINMENT ACTION, MANUFACTURING PERSONNEL WERE NOTIFIED ABOUT THE ISSUE. A CAPA REQUEST WAS ISSUED IN ORDER TO INVESTIGATION AND ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE ET TUBE PACKAGE IS LABELED 8.0MM, HOWEVER THE SIZE STAMPED ON THE TUBE IS 7.5MM. THE ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448968 HUDSON ENDOTRACHEAL TUBE, CF, 8.0 ENDOTRACHEAL TUBE BTR TELEFLEX 01A1400211

    Patients

    Seq Age Sex Outcome Treatment
    1