BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERIDAN

    MDR report key: 93593 · Received May 23, 1997

    Report

    Report Number
    93593
    Event Type
    Injury
    Date Received
    May 23, 1997
    Date of Event
    November 27, 1996
    Report Date
    January 10, 1997
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT REINTUBATED FIVE TIMES DUE TO ET TUBE CUFF LEAKING #8.5 AND 9.0 TUBES. ONE TUBE SMALL HOLE IDENTIFIED IN CUFF. THREE ET TUBES SAVED FOR RETURN. ONE TUBE HOLE IDENTIFIED PRIOR TO PLACEMENT. .02 SATURATIONS DOWN TO 70 DURING ET TUBE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN ENDOTRACHEAL TUBE BTR SHERIDAN CATHETER CORP. * 020909

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| O| R