BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA CUFFLESS FENESTRATED TRACHEOSTOMY

    MDR report key: 157629 · Received March 16, 1998

    Report

    Report Number
    2029387-1998-00003
    Event Type
    Malfunction
    Date Received
    March 16, 1998
    Date of Event
    December 16, 1997
    Report Date
    January 12, 1998
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ONE (1) 6DCFN WAS RETURNED TO THE MFR 2/24/1998 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA CUFFLESS FENESTRATED TRACHEOSTOMY Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6DCFN & 6DIC M75799000

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR PB 2800 VENTILATOR, VARIOUS CONNECTORS/ADAPTORS| (MFR. MODEL TYPES UNKNOWN).