BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3791815 · Received January 21, 2014

    Report

    Report Number
    9611710-2014-00029
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 30, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. PRODUCT WAS NOT USED. ADD'L EVENT DETAILS HAVE BEEN REQUEST. NO ADD'L INFO HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CONTAMINATION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51022 ENTOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 66D1486 615923R002

    Patients

    Seq Age Sex Outcome Treatment
    1