BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2977792 · Received January 23, 2013

    Report

    Report Number
    9611710-2013-00013
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON PRIVATE LABEL COMPLAINTS FROM OUR FACILITY IN (B)(4). THIS IS RELATED TO ((B)(4)). BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS IS A SERIOUS MALFUNCTION. A LEAKING ENDOTRACHEAL/TRACHEOSTOMY TUBE CUFF EXPOSES THE PATIENT TO THE RISK OF ASPIRATION OF GASTRIC CONTENTS AND A REDUCTION IN VENTILATION PRESSURE. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS RECEIVED BY (B)(6) ON (B)(6) 2012 FROM JSS CORPORATION FOR PRODUCT REINFORCED TUBE SIZE 8.5MM. CUSTOMER COMPLAINING:" AIR LEAK OCCURED DURING USE AT SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33839 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHAEL BTR UNOMEDICAL SDN BHD 61214085IJ 610172R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening