BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MGMT

    MDR report key: 3972901 · Received April 28, 2014

    Report

    Report Number
    9611710-2014-00070
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 26, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE EVENT HAPPENED WHILE PT WAS IN THE MEDICAL HIGH DEPENDENCY UNIT 2. NO PT INFO WAS PROVIDED. THE REPORTED ISSUE WAS NOTED UPON OPENING THE PACKAGE AS THE PRODUCT WAS NOT YET IMPLEMENTED ON THE PT. ADDITIONAL INFO VIA EMAIL DATED (B)(6) 2014 REPORTS "CUSTOMER CONFIRMED THAT ONLY SAID BATCH HAS THE PROBLEM." ADDITIONAL FOLLOW-UP INFO PROVIDED VIA EMAIL ON 04/14/2014, REPORTED THAT THE "SHIP DATE TO CUSTOMER WAS ON (B)(4) 2013. COMPLAINT EVENT DATE REPORTED BY CUSTOMER ON (B)(6) 2014. HENCE, THE PRODUCT REMAIN WITH CUSTOMER FOR ABOUT A YEAR. HOWEVER, DOCTOR OCCURRED PROBLEM WHILE USING THE PRODUCT ON PT." ADDITIONAL INFO VIA EMAIL DATED 04/15/2014 NOTES THE FOLLOWING COMPLAINT ISSUE WAS CONFIRMED BEING RECEIVED BY THE PHARMANIAGA ON (B)(6) 2014 AND THE MINISTRY OF HEALTH (THE EXACT DATE THE ISSUE WAS REPORTED TO THE (B)(4) MINISTRY OF HEALTH WAS NOT INDICATED). A QUALITY EVALUATION WAS PERFORMED ON 04/24/2014. RECEIVED WAS ONE UNUSED ENDOTRACHEAL TUBE OF I.D. 7.0 MM AND PILOT BALLOON PRINTED WITH SIZE IDENTIFICATION AND WORK ORDER # (B)(4). THE PRODUCT WAS EXAMINED AND TESTED ON 04/18/2014, 04/21/2014, AND 04/22/2014. NO SIGNS OF KINK OR DISTORTION ON THE TUBE SURFACE THAT COULD POTENTIALLY LEAD TO TUBE COLLAPSE DURING USE WERE DETECTED. THE BALLOON EASILY INFLATED WITH AIR AND DEFLATION WAS EASY AND NORMAL. THE CONNECTOR WAS CAREFULLY REMOVED AND ONE THIN SPECIMEN FROM THE SAMPLE MEASURING APPROXIMATELY 1MM THICK WAS TAKEN APPROXIMATELY 10MM AWAY FROM THE MACHINE END OF TUBE FOR MEASUREMENT USING THE SMART SCOPE AND THE DIMENSION WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE CONNECTOR WAS RE-ASSEMBLED TO THE TUBE AND THE TUBE WAS SUBJECTED TO COLLAPSED TEST. NO SIGN OF TUBE COLLAPSE WAS FOUND AT THE END OF THE 24 HRS CONDITIONING PERIOD. A STEEL BALL (W/DIMENSION 5.35) PASSED FREELY THROUGH THE TUBE WITHOUT ANY OBSTRUCTION. THE TUBE COOL DOWN BEFORE SUBJECTED TO HARDNESS TEST. HARDNESS TESTING AVERAGE WAS 86.0 AND FOUND TO BE WITHIN SPECIFICATION OF 85-89 AND THEREFORE, CONSIDERED "ACCEPTABLE". REVIEW OF INCOMING TEST REPORT FOR HARDNESS TEST RECORD REVEALED THAT THIS BATCH WAS CONSIDERED ACCEPTABLE AT THE POINT OF RELEASE. REVIEW OF THE RISK ASSESSMENT FILE DOES COVER POTENTIAL CAUSE (KINK TUBE ISSUE) AND IT'S CONTROLLED. AN INVESTIGATION ON THE REP SAMPLE SHOWED THAT IT MET SPECIFICATION AS THE SAMPLE PASSED THE COLLAPSED TEST. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 04/25/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE "TUBE EASILY BENDS (TOO ELASTIC)". IT WAS FURTHER STATED THAT THE "ANESTHESIOLOGIST IN THE INTENSIVE CARE UNIT DOES NOT LIKE THE ENDOTRACHEAL TUBE BECAUSE, IT EASILY BENT AND THE PT WILL BE EASILY EXPOSED TO THE RISK OF HAVING THE TUBES ACCIDENTALLY CAME OUT FROM THE MOUTH (EASY TO LEAK)"; IT WAS ALSO STATED "PT MAY NOT BE HAVING ADEQUATE VENTILATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253599 ENDOTRACHEAL TUBES - AIRWAY MGMT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61110070 611124R004

    Patients

    Seq Age Sex Outcome Treatment
    1