BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 168700 · Received May 21, 1998

    Report

    Report Number
    168700
    Event Type
    Malfunction
    Date Received
    May 21, 1998
    Date of Event
    May 15, 1998
    Report Date
    May 21, 1998
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON MONTHLY TRACH TUBE CHANGE HOME HEALTH RN WAS UNABLE TO INSERT 2 DISPOSABLE TRACH TUBES BY SHILEY. ONE WAS A TOP ROUND. THE OTHER'S CUFF WAS TOO THICK TO ALLOW IT TO BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC. * 9399182300; M77674000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR