BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, CF, 4.0 MM

    MDR report key: 3837558 · Received March 3, 2014

    Report

    Report Number
    3003898360-2014-00120
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 5, 2014
    Manufacturer
    TELEFLEX
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. A DOCUMENT ASSESSMENT WAS CONDUCTED AND NO CHANGES WERE 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 CUSTOMER ALLEGES THAT THE CUFF OF THE ENDOTRACHEAL TUBE IS INFLATING TO ODD SIZES. THE ALLEGED ISSUE OCCURRED DURING USE. THE CUSTOMER STATES THAT THE DEFECT CAUSED A TRACHEAL LACERATION IN A PET. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127053 HUDSON ET TUBE, CF, 4.0 MM ENDOTRACHEAL TUBE JOH TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1