BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT TRACHEAL TUBE, 8.0

    MDR report key: 2994167 · Received March 1, 2013

    Report

    Report Number
    3003898360-2013-00080
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 7, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OUTCOME OF THE CODE (CPR) RESULTED IN A PT DEATH. THE PERSON WHO INTUBATED THE PT INDICATED THAT THE ETT (ENDOTRACHEAL TUBE) HAD NOTHING TO DO WITH THE PT'S DEATH. THIS INFORMATION WAS SUPPORTED BY THE RISK MANAGER (B)(6) OF THE USER FACILITY WHO, IN TURN, STATED THAT THE DOCTOR WHO WAS PRESENT DURING THE CODE (CPR) EFFORTS MADE THIS CLAIM. THE RISK MANAGER ALSO INDICATED THAT THE FACILITY WOULD NOT RELEASE THE DEVICE SAMPLE. HOWEVER, A REPRESENTATIVE COULD VIEW THE DEVICE AT THE USER FACILITY. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED, VIA MEDWATCH, FROM THE USER FACILITY AS: "PATIENT WAS INTUBATED DURING A CODE WITH A 8.0 ENDOTRACHEAL TUBE. PRIOR TO INTUBATION THE CUFF/PILOT BALLOON WAS CHECKED AND WORKED PROPERLY. ONCE THE ETT WAS PLACE, WHEN TRYING TO INFLATE THE PILOT BALLOON RESISTANCE WAS MET AND THE PILOT BALLOON REMAINED DEFLATED. AFTER MULTIPLE ATTEMPTS TO INFLATE THE PILOT BALLOON A TUBE EXCHANGER WAS USED TO REPLACE THE ETT WITH ANOTHER 8.0 ETT AND THAT PILOT BALLOON WAS PROPERLY INFLATED. LATER, WHILE INSPECTING THE ETT WITH THE MALFUNCTIONING PILOT BALLOON, IT WAS DISCOVERED THAT EVEN THOUGH THE PILOT BALLOON WAS DEFLATED THE ACTUAL CUFF WAS COMPLETELY INFLATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89536 HUDSON SHERIDAN/HVT TRACHEAL TUBE, 8.0 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR