BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3830016 · Received May 8, 2014

    Report

    Report Number
    9611710-2014-00117
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    February 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. A REQUEST FOR CLARIFICATION OF INFO DOCUMENTED ON THE COMPLAINT FORM REQUESTED ON (B)(4) 2014. THE FOLLOWING ADDITIONAL INFO WAS RECEIVED VIA E-MAIL ON (B)(4) 2014 FOR CLARIFICATION OF EVENT DETAILS IT WAS REPORTED THAT THE PRODUCT WAS NOT REINSERTED OR DISCONTINUED; THE PRODUCT WAS USED ONE HOUR PRIOR TO THE REPORTED EVENT; NO INFO WAS PROVIDED ON THE PT'S OUTCOME. IT WAS STATED ON THE COMPLAINT FORM THAT THE "USER OF THE PROBE IS A PROFESSIONAL OF THE HEATH. HE IS VERY COMPETENT AND HIGHLY QUALIFIED AND HE CAN NOT SEE IT'S INDEED A DEFECT IN THE DEVICE". NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE INTUBATION ARMY REGARDING THE REPORTING DOES NOT ALLOW VENTILATION OF THE PT, WHERE THE PT EXTUBATION AND REINTUBATION PROBE OF ANOTHER BRAND. WE ALSO NOTE THE DISSECTION OF THE INTERNAL FOUND OF THE PROBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278277 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61224170 611066R001

    Patients

    Seq Age Sex Outcome Treatment
    1