BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERIDAN

    MDR report key: 20538 · Received March 7, 1995

    Report

    Report Number
    20538
    Event Type
    Injury
    Date Received
    March 7, 1995
    Date of Event
    August 29, 1994
    Report Date
    September 8, 1994
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ON 8/20/94, A 16 Y/O FEMALE TRAUMA PATIENT WAS INTUBATED IN OUR ER BY A PHYSICIAN. THE ENDOTRACHEAL TUBE CUFF WAS CHECKED PRIOR TO INTUBATION. PATIENT WAS TRANSFERED TO A TRAUMA CENTER WITH THE ENDO TRACHEAL TUBE INTACT. ON 8/29/94 AN ATTEMPT TO EXTUBATE THE PATIENT AT THE TRAUMA CENTER REVEALED THAT THE CUFF WOULD NOT DEFLATE. SEVERAL METHODS WERE USED TO DEFLATE THE CUFF BUT WERE UNSUCCESSFUL, INCLUDING CUTTING THE CUFF PORT. THE PATIENT WAS THEN EXTUBATED BY A TRAUMA PHYSICIAN WITH THE CUFF INFLATED. ACCORDING TO THE PHYSICIAN, THE CUFF HAD TO BE MANUALLY "SQUEEZED" TO DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN ENDO TRACHEAL TUBE BSK SHERIDAN CATHETER CORP. 018983

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization PATIENT HAS A TRACHEAL TEAR, POSSIBLY THE RESULT| OF EXTUBATION WITH THE CUFF INFLATED.