BEUDAMED
    FDA Adverse Event Death Summary report: N

    SATIN-SLIP/SATIN-SLIP

    MDR report key: 326674 · Received April 16, 2001

    Report

    Report Number
    326674
    Event Type
    Death
    Date Received
    April 16, 2001
    Date of Event
    October 24, 2000
    Report Date
    February 15, 2001
    Manufacturer
    MALINCKRODT, INC.
    Product Code
    BSR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    STYLET FROM 3.0 ETT DIFFICULT TO REMOVE WITH INITIAL INTUBATION. TUBE AT 14 CM, PULLED BACK TO 7 CM. HEART RATE 50'S; STARTED CHEST COMPRESSIONS, PULLED KIT AND REINTUBATED. RIGHT CHEST NEEDLED WITH #23 BUTTERFLY, IMMEDIATE BUBBLING NOTED; 30 CC EVACUATED WITH SYRINGE. NO SUSTAINED HEART RATE DESPITE MULTIPLE EPINEPHRINE AND SODIUM BICARBONATE. PRONOUNCED AT 1030. PRELIMINARY AUTOPSY REPORT NOTED 2MM X 1MM DEFECT AT JUNCTION OF RIGHT MIDDLE, UPPER AND LOWER LOBES. THE FINAL AUTOPSY REPORT INDICATED DEATH DUE TO A TENSION PNEUMOTHORAX WITH THE SOURCE OF THE PNEUMOTHORAX A DEFECT IN THE RIGHT PULMONARY PARENCHYMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17206 SATIN-SLIP/SATIN-SLIP INTUBATING STYLET W/CUFFED ENDOTRACHEAL TUBE BSR MALINCKRODT, INC. * UNK/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death