BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC MAGILLE ENDOTRACHEAL TUBE 3.0MM

    MDR report key: 6211208 · Received December 28, 2016

    Report

    Report Number
    9611710-2016-00150
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    October 19, 2016
    Report Date
    December 7, 2016
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE ENDOTRACHEAL TUBE WAS INSPECTED. THERE IS NO VISIBLE OBSTRUCTION SEEN INSIDE THE ET TUBE. SINCE THE CUSTOMER DID NOT RETURN THE SUCTION CATHETER REFERRED TO IN THE COMPLAINT DESCRIPTION, AN UNUSED HALYARD 6FR (CODE 196-5, LOT M4132T503) CLOSED SUCTION CATHETER WAS USED IN THIS EVALUATION. THE CONNECTION OF THE INFLATION LINE TO THE ET TUBE WAS EXAMINED UNDER MAGNIFICATION. NO ENCROACHMENT INTO THE ET TUBE WAS OBSERVED. THE 6FR HALYARD SUCTION CATHETER WAS ADVANCED THROUGH THE RETURNED ET TUBE. THE SUCTION CATHETER PASSED EASILY THROUGH THE ET TUBE WITH NO RESISTANCE FELT. THE REPORTED FAILURE WAS NOT REPRODUCED USING THE REPRESENTATIVE HALYARD SUCTION CATHETER WITH THE USED ET TUBE. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON DECEMBER 28, 2016. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS ADDITIONAL DATA WAS RECEIVED FROM THE COMPLAINANT, WHO REPORTED THAT THE PRODUCT WAS USED FOR LONG TERM RESPIRATORY SUPPORT ON THE PATIENT. IT WAS NOTED HOWEVER, THAT THE THERE WERE NO REPORTS OF RESPIRATORY DISTRESS. THE DEVICE WAS PLACED IN USE FOR THREE (3) HOURS BEFORE BEING REPLACED WITH AN UNKNOWN BRAND. IT WAS ALSO REPORTED THAT THE PATIENT HOSPITALIZATION WAS NOT EXTENDED DUE TO THE REPORTED EVENT. THE LOT INFORMATION WAS NOT PROVIDED FROM THE CUSTOMER, BUT RATHER THE DISTRIBUTOR WHICH REPORTED THAT, "THERE WERE TWO (2) LOT NUMBER'S PROVIDED FROM OUR SHIPPING RECORD, THE LOT NUMBER'S IS EITHER (UM4304XXX/UM5056XXX)", HOWEVER NO VALID LOT NUMBER COULD BE OBTAINED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JANUARY 20, 2017. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE SECOND OR THIRD TIME OF SUCTION OPERATION THE SUCTION CATHETER STOPPED AT THE POINT OF CUFF LOCATION AND WOULD NOT GO THROUGH THE TUBE. THERE WAS NO PROBLEM REPORTED AT THE FIRST SUCTION. THE MICROCUFF WAS REPLACED AND THE PROBLEM WAS SOLVED WITH NO HEALTH INJURY TO THE PATIENT. NO VISIBLE OBSTRUCTION WAS SEEN INSIDE THE ET TUBE UPON INSPECTION. PHOTOGRAPHS WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858966 PEDIATRIC MAGILLE ENDOTRACHEAL TUBE 3.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35111

    Patients

    Seq Age Sex Outcome Treatment
    1