BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHERIDAN HVT TRACHEAL TUBE

    MDR report key: 614658 · Received July 19, 2004

    Report

    Report Number
    2014730-2004-00007
    Event Type
    Other
    Date Received
    July 19, 2004
    Date of Event
    June 5, 2004
    Report Date
    July 16, 2004
    Manufacturer
    HUDSON RESPIRATORY CARE, INC., TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER CLAIMED THAT A PATIENT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE THAT CONTAINED FADED TO UNREADABLE MARKINGS. THE USER INDICATED THAT THEY WERE AWARE THAT THE MARKINGS WERE FADED PRIOR TO INTUBATION. DURING INTUBATION THE PATIENT COUGHED, PROJECTING THE TUBE FORWARD. A PORTABLE CHEST X-RAY REVEALED THAT THE ENDOTRACHEAL TUBE WAS INSERTED TOO DEEP INSIDE THE PATIENT'S AIRWAY (T-1 LEVEL). USER CLAIMED THAT THE BALLOON BURST AND DIDN'T HOLD AIR, REQUIRING RE-INTUBATION. THERE WAS NO PATIENT INJURY OR LONG TERM ADVERSE EFFECTS TO THE PATIENT. THE MANUFACTURER RECEIVED PRODUCT INVOLVED IN THE ALLEGED INCIDENT. FUNCTIONAL TESTING AND VISUAL INSPECTION DEMONSTRATED THAT THE CUFF AND BALLOON WERE INTACT AND DID NOT LEAK. VISUAL INSPECTION DID CONFIRM SOME OF THE MARKINGS ON THE TUBE WERE FADED AND/OR UNREADABLE. THE HOSPITAL VERIFIED THAT ALL PRODUCTS IN STOCK HAD APPROPRIATE MARKINGS. A REVIEW OF MANUFACTURING DOCUMENTATION IDENTIFIED NO REJECTS FOR MISSING MARKINGS. THIS INCIDENT WAS DETERMINED TO BE AN ISOLATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN HVT TRACHEAL TUBE 7.0 ENDOTRACHEAL TUBE BTR HUDSON RESPIRATORY CARE, INC., TELEFLEX MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other