BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY SPECIALIZED TRACHEOSTOMY TUBE

    MDR report key: 57207 · Received December 18, 1996

    Report

    Report Number
    2029387-1996-00166
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    November 1, 1996
    Report Date
    December 11, 1996
    Manufacturer
    MALLINCKRODT MEDICAL , INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA LENGTH ON ONE (1) SIZE M6.5 SCT, SPECIALIZED TRACHEOSTOMY TUBE WAS TOO SHORT. THIS WAS DETECTED DURING PROCEDURE SET-UP FOR A SCHEDULED TRACH TUBE CHANGE. A SECOND DEVICE WAS AVAILABLE. THERE WAS NO DIRECT PT INVOLVEMENT OR REPORTED PT COMPROMISE. THE M6.5 SCT DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SPECIALIZED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL , INC. M6.5SCT M6668300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA