BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 196073 · Received October 30, 1998

    Report

    Report Number
    196073
    Event Type
    Malfunction
    Date Received
    October 30, 1998
    Date of Event
    October 25, 1998
    Report Date
    October 28, 1998
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NOTICED TRACH TUBE WAS MOVING WHEN PREPARING TO MOVE PT TO HAVE X-RAYS DONE. TUBE WAS SUTURED TO PT. UPON FURTHER INVESTIGATION NOTED TRACH WAS BROKEN AT THE NECKPLATE AND OUTER CANNULA ON THE LEFT SIDE. RESPIRATORY THERAPIST CALLED TO CHANGE OUT TRACH. CHANGED WITH SAME TYPE OF PRODUCT WITH NO PROBLEMS. ORIGINAL NEW TRACH PROCEDURE DONE ON 10/21/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE 8DCT. DISPOSABLE LOW PRESSURE CUFFED. BTO MALLINCKRODT MEDICAL TPI, INC. 8 DCT *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR