BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORFAST

    MDR report key: 5116398 · Received October 1, 2015

    Report

    Report Number
    5116398
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 21, 2015
    Report Date
    September 23, 2015
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR HOLLISTER ANCHORFAST ENDOTRACHEAL TUBE HOLDERS COMING FROM TWO SEPARATE LOTS BROKE IN THE SAME FASHION. THE PORTION OF THE TUBE HOLDER THAT RUNS PARALLEL TO THE ENDOTRACHEAL TUBE AS IT ENTERS THE PATIENT'S MOUTH BROKE OFF AT THE SECOND NOTCH FROM THE TOP. SOME OF THESE BREAKS OCCURRED BEFORE THE PACKAGE WAS OPENED AND THE BROKEN PIECE CAN BE SEEN INSIDE THE UNOPENED PACKAGE. ALL THE DEVICES THAT COMPRISED THE TWO MALFUNCTIONING LOTS WERE TAKEN OUT OF CIRCULATION. FOUR TOTAL FROM LOT NUMBER: 5E042 WERE SECURED AND SENT TO CLINICAL ENGINEERING. OF THESE FOUR, TWO OF THEM WERE NOTED TO BE BROKEN IN THEIR UNOPENED PACKAGING. NINETEEN TOTAL FROM LOT NUMBER: 5H072 WERE SENT TO CLINICAL ENGINEERING. ALL OF THESE APPEAR TO BE INTACT AND WERE TAKEN OFF THE SHELVES AS A PRECAUTIONARY MEASURE DUE TO THE FAILURE OF ONE UNIT FROM THIS LOT. MANUFACTURER RESPONSE FOR ORAL ENDOTRACHEAL TUBE FASTENER, ANCHORFAST (PER SITE REPORTER): I LEFT A MESSAGE WITH THE HOLLISTER INC. QUALITY ASSURANCE DEPARTMENT, THEY WILL RETURN MY CALL WITHIN 24 BUSINESS HOURS TO OFFICIALLY FILE THE COMPLAINT AND SCHEDULE RETURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646530 ANCHORFAST ENDOTRACHEAL TUBE BTR HOLLISTER INCORPORATED 5E042

    Patients

    Seq Age Sex Outcome Treatment
    1