BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY TRACHEOSTOMY TUBE

    MDR report key: 12640 · Received March 30, 1994

    Report

    Report Number
    12640
    Event Type
    Death
    Date Received
    March 30, 1994
    Date of Event
    March 16, 1994
    Report Date
    March 18, 1994
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DISLODGED TRACH TUBE (HANDS RESTRAINED) AND DEVELOPED RESPIRATORY DISTRESS. UNSUCCESSFUL ATTEMPTS TO REINTUBE ORALLY AND REINSERT TRACH TUBE, #8 ENDO TUBE INSERTED INTO TRACH SITE AT 1600 HOURS, BUT CONTINUED DIFFICULTY PRESENT WITH VENTILATING PT. PT WENT INTO FULL CODE. DEATH RESULTED AFTER DISLODGING TRACH TUBE AND UNSUCCESSFUL ATTEMPTS TO REINTUBATE AND ADEQUATELY VENTILATE. PHYSICIAN EXPRESSED CONCERN OVER DESIGN FAILURE OF TRACH TUBE. HE FEELS THAT THE TRACH TUBE WAS NOT LONG ENOUGH. SIZES 8 AND 10 COME WITH A STANDARD LENGTH OF 84 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE Implant BTO MALLINCKRODT MEDICAL TPI, INC. DCT SIZE 8 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death