BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE, 2.5MM

    MDR report key: 3020711 · Received March 18, 2013

    Report

    Report Number
    3003898360-2013-00105
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 1, 2011
    Report Date
    March 5, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTER LOT NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. FMEA (PRODUCT/PROCESS) - ASSESSMENT WAS CONDUCTED AND NO CHANGES REQUIRED. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS 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: THE SUCTION CATHETER CANNOT PASS THROUGH THE END OF THE TUBE. THE ALLEGED DEFECT OCCURRED WHILE PRE-TESTING FOR PATIENT USE. NO PATIENT INJURY/INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111943 HUDSON SHERIDAN UNCUFFED TRACHEAL TUBE, 2.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01C1200377

    Patients

    Seq Age Sex Outcome Treatment
    1