BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY LOW PRESSURE

    MDR report key: 20130 · Received March 3, 1995

    Report

    Report Number
    MW1005324
    Event Type
    Malfunction
    Date Received
    March 3, 1995
    Report Date
    March 2, 1995
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OUTER CANNULA CRACKS WHICH PREVENTS THE INNER CANNULA FROM BEING LOCKED IN SECURELY. THE LAST ONE CRACKED AFTER SEVEN DAYS. THE REPORTER STATED THAT 12 CANNULAS HAVE CRACKED IN THE LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE TRACHEOSTOMY TUBE, #6 BTO MALLINCKRODT MEDICAL TPI, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR