BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3912370 · Received May 13, 2014

    Report

    Report Number
    9611710-2014-00113
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    June 9, 2011
    Report Date
    July 18, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K96238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. TWO (2) UNUSED SAMPLES RECEIVED ON (B)(4) 2011 AND TESTED ON (B)(4) 2011 RESULTS FROM THE INVESTIGATION ARE AS FOLLOWS: TUBES WERE REMOVED AND CAREFULLY EXAMINED. IMPROPER PRODUCT INDICATION AS MARKED BY THE CUSTOMER WAS CONFIRMED. RING MARK WAS NOT PRINTED ON THE TUBE AFTER THE '26 GRADUATION MARKING' WAS OBSERVED, AND WAS CONSIDERED "NOT ACCEPTABLE" AS PER INSPECTION CRITERIA. REVIEW OF ASSEMBLY RECORDS SHOWED NO SIGNS OF ASSOCIATED DEFECTS DETECTED DURING THE 100% LIGHT TEST. BASED ON THE FINDINGS, IT IS CONCLUDED THAT THE COMPLAINT WAS CONFIRMED AS PER RETURNED SAMPLES. AN INTERNAL CORRECTIVE ACTION EVENT HAS BEEN TAKEN FOR A SIMILAR COMPLAINT, AND THIS PARTICULAR LOT (608051R001) IDENTIFIED WAS CONFIRMED TO BE MANUFACTURED BEFORE IMPLEMENTATION OF THE CAPA. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY (B)(4) FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - (B)(4) 2013. (B)(4) WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO (B)(4)COMPLAINT HANDLING AND CAPA.

    Description of Event or Problem · 1

    DETAILS OF THE COMPLAINT: "QTY : 1; IMPROPER PRODUCT INDICATION: NO INDICATION FOR 27'S LINE AS PER ATTACHED PHOTO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285585 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) 73BTR BTR UNOMEDICAL SDN BHD 61214065 608051R001

    Patients

    Seq Age Sex Outcome Treatment
    1