BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2945117 · Received January 31, 2013

    Report

    Report Number
    9611710-2013-00056
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    October 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON AVAILABLE INFO, OUR MED DETERMINATION IS THAT THIS IS A SERIOUS MALFUNCTION. A RECURRENCE DURING USE COULD COMPROMISE PT'S VENTILATION WHICH COULD BE LIFE THREATENING. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    (B)(4). THIS COMPLAINT WAS REC'D BY (B)(4) ON (B)(4) 2011 FROM (B)(6) FOR PRODUCT REINFORCED TUBE SIZE 8.5MM. CUSTOMER COMPLAINING: "WHEN CUFF INFLATED, INSIDE OF TUBE IS BLOCKED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43505 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 66D1495 608790R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening