BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 3030925 · Received March 28, 2013

    Report

    Report Number
    9611710-2013-00232
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    November 26, 2012
    Report Date
    March 5, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, OUR MEDICAL DETERMINATION IS THAT THIS IS A SERIOUS MALFUNCTION. A LEAKING ENDOTRACHEAL/TRACHEOSTOMY TUBE CUFF EXPOSES THE PT TO THE RISK OF ASPIRATION OF GASTRIC CONTENTS AND A REDUCTION IN VENTILATION PRESSURE. ALTHOUGH THERE IS A POTENTIAL FO A SERIOUS INJURY, THE LIKELIHOOD OF SUCH AN OCCURRENCE IS LOW BECAUSE THESE DEVICES UNDERGO RIGOROUS TESTING AND ARE ONLY USED IN HIGHLY MONITORED AND HIGHLY SPECIALIZED SETTINGS. A LEAKING CUFF WOULD LIKELY TRIGGER ALARMS TO ALERT CARE-GIVERS AND IN MOST CASES ALL THAT IS REQUIRED IS A SIMPLE RE-INFLATION BY THE BEDSIDE. HOWEVER, IN SOME CASES OF A RAPID LEAK, THE PT MAY REQUIRE A COMPLETE RE-INTUBATION. THIS PROCEDURE, IF CARRIED OUT IN EXPERT, EXPERIENCED HANDS, HAS A LOW INCIDENCE OF SERIOUS COMPLICATIONS. BASED ON INVESTIGATION RESULTS, WE COULD NOT DETERMINE THE CAUSE FOR SUCH A BIG CUFF TEAR, ESPECIALLY WITH 100% INFLATION/DEFLATION TEST AS WELL AS VISUAL INSPECTION. IT'S POSSIBLE THE TEAR COULD HAVE BEEN INDUCED DURING PRODUCT USAGE, I.E. CUFF CONTACTED WITH SHARP OBJECT SUCH AS LARYNGOSCOPE ETC. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "THE LEAKAGE OF THE CUFF WAS NOTED IN USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128371 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD MM61110075 606533R008

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening