BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN ENDOTRACHEAL TUBE, HVT, 5.0

    MDR report key: 1954626 · Received January 5, 2011

    Report

    Report Number
    3003898360-2011-00025
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ON (B)(6) 2010 DR (B)(6), WAS PERFORMING A ROUTINE DENTAL PROCEDURE ON A 3 1/2 YEAR OLD HOUSE DOG WHEN DURING SURGERY, IT WAS NOTED THAT THE PATIENT'S HEART RATE DECREASED AND PT WAS TURNING A BLUE COLOR. IT WAS ALSO NOTICED THAT THE OXYGEN FLOW WASN'T CONSISTENT, SO THE DOCTOR EXTUBATED THE PT AND RE-INTUBATED THE PT, HOWEVER, BY THAT TIME THE PT EXPIRED. DR (B)(6) ALLEGES THAT UPON EXAMINING THE TUBE; IT WAS NOTED TO BE OCCLUDED WITH WHAT HE DESCRIBED AS A SMALL, CLEAR, RUBBERY-LIKE SUBSTANCE. THE SUBSTANCE WAS LOCATED APPROX 5MM BELOW THE TOP OF THE CUFF. DR (B)(6) STATED THAT THE SUBSTANCE WASN'T NOTED PRIOR TO INTUBATION AND TO HIS KNOWLEDGE; THE TUBE WAS NEW OUT OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERIDAN ENDOTRACHEAL TUBE, HVT, 5.0 ENDOTRACHEAL BTR TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5 YR Death