BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3869006 · Received April 25, 2014

    Report

    Report Number
    9611710-2014-00072
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    P951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. AN INVESTIGATION WAS CONDUCTED ON (B)(4) 2011 BASED EVALUATION OF THE RETURNED SAMPLE. DATE TESTED ARE (B)(4) 2011; REVIEW OF PRIMARY PRODUCTION BATCH RECORD SHOWED PROCESSES WERE OPERATING WITHIN THE ESTABLISHED PARAMETERS. IT IS CONCLUDED THAT COMPLAINT COULD NOT BE PERFORMED AS PER THE RETURNED SAMPLE. THE INTERNAL DIAMETER WAS FOUND TO HAVE MET THE SPECIFICATION WHEN MEASURED. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - (B)(4) 2013. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF THE REPORT IS AS FOLLOWS: "BEFORE USING THE ETT-SUCTION IN A CLINIC WE TRIED TO USE A BRONCHOSCOPE. IT WAS NOT POSSIBLE TO PASS THE TUBE WITH A REGULAR BRONCHOSCOPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250487 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBES, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61114285 605899R001

    Patients

    Seq Age Sex Outcome Treatment
    1