BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 4041057 · Received August 12, 2014

    Report

    Report Number
    2936999-2014-00759
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 4, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THE TUBE EXHIBITED A COMPLETE PRINTING ARTWORK ACCORDING TO DRAWINGS, PLUS THE PRINTING RINGS WERE PRESENT. NO FAILURE MODE WAS OBSERVED IN THE RECEIVED SAMPLE, AND THE CUSTOMER REPORTED MALFUNCTION WAS NOT VERIFIED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT REC'D STATED, DURING PRIOR TO USE TESTING, A NURSE APPLIED XYLOCAINE SPRAY TO THE INTERNAL TRACHEAL TUBE. FOLLOWING THE APPLICATION OF THE XYLOCAINE SPRAY, THE TUBE WAS PLACED IN THE ORIGINAL PACKAGE UNTIL THE PATIENT WAS READY FOR INTUBATION. UPON INSPECTING THE DEVICE, BEFORE USE, THE MARKER PRINT WAS FOUND TO HAVE DISAPPEARED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479428 MALLINCKRODT TRACHEOSTOMY TUBE BTR COVIDIEN 14A0766JZK

    Patients

    Seq Age Sex Outcome Treatment
    1