BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2980428 · Received February 22, 2013

    Report

    Report Number
    9611710-2013-00155
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    November 29, 2011
    Report Date
    November 29, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BSR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN REVIEWED, AND DEEMED A MALFUNCTION. BASED ON CURRENT INFO, RECURRENCE OF THIS MALFUNCTION WOULD LIKELY LEAD TO A SERIOUS ADVERSE EVENT INVOLVING DAMAGE TO THE AIRWAY RESULTING IN EVENTUAL SCARRING, AND/OR RESPIRATORY DISTRESS AND/OR A DISRUPTION OF VITAL SURGERY IF IT WERE TO OCCUR IN THE OPERATING ROOM. REPORT TO FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO ((B)(4)). COMPLAINT REVEALED AS FOLLOWS: "WHEN BEING INSERTED, AS MATERIAL IS TOO SOFT, THE DEVICE TWISTED ON ITSELF CAUSING HYPERPRESSION AND AVOIDING PT VENTILATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77433 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHAEL BSR UNOMEDICAL SDN BHD MM61213045 600303R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening