BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE

    MDR report key: 2934760 · Received January 23, 2013

    Report

    Report Number
    3003898360-2013-00026
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 29, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEWED WAS CONDUCTED ON THE REPORTED LOT NUMBER. UPON REVIEWED IT WAS OBSERVED THAT THE LOT NUMBER REPORTED, CORRESPONDS TO ONE OF THE LOTS IDENTIFIED TO BE AFFECTED WITH THE BESPACK VALVE. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; THE LOT NUMBER REPORTED ON THIS COMPLAINT CORRESPONDS TO ONE OF THE LOTS IDENTIFIED TO BE AFFECTED WITH THE BESPAK VALVE ISSUE. HOWEVER, THE CORRECT THIS SITUATION FOR SIMILAR COMPLAINTS REC'D IN THE PAST, A SUPPLIER CORRECTION ACTION (B)(4) REQUEST WAS ISSUED TO THE VALVE VENDOR AND A CAPA#(B)(4) WAS OPENED TO IMPROVE THE PROCESS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER REPORTS HAVING DEFLATION ISSUES WITH THE ET TUBE CUFF. THE ISSUE WAS DISCOVERED DURING PRE-TESTING OF THE CUFF PRIOR TO PT INTUBATION. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33230 HUDSON SHERIDAN/HVT TRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL 01E12004551

    Patients

    Seq Age Sex Outcome Treatment
    1