BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE HYPERFLEX TUBE, CUFFLESS

    MDR report key: 148640 · Received February 6, 1998

    Report

    Report Number
    1824231-1998-00002
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Date of Event
    December 24, 1997
    Report Date
    January 14, 1998
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SILICON "GODS" DESTROYED 5 MM BELOW CONNECTOR. THE TUBE HAS BEEN IN PT FOR 3 WEEKS. WASHED BY HAND. PLACED IN PT AGAIN FOR ANOTHER 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE HYPERFLEX TUBE, CUFFLESS TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES NA 560440

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Hospitalization