BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3874226 · Received April 23, 2014

    Report

    Report Number
    9611710-2014-00068
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 25, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE ISSUE WAS NOTED DURING PRETESTING AND THE DEVICE WAS NOT INTRODUCED TO THE PATIENT. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING PRETESTING THE MEDICAL STAFF DEFLATED THE PILOT BALLOON, BUT THE CUFF DEFLATION WAS NOT COMPLETE AND THEY FELT THE RESISTANCE WHEN THEY TRIED TO DEFLATE THE PILOT BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245077 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61313070 614200R001

    Patients

    Seq Age Sex Outcome Treatment
    1