BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3902466 · Received May 7, 2014

    Report

    Report Number
    9611710-2014-00094
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. AN EVALUATION WAS PERFORMED ON (B)(4) 2014. RECEIVED THREE UNUSED I.D 5.5MM, CATALOG#: 61110055 ENDOTRACHEAL TUBES WITH FROSTY BALLOONS, FITTED WITH PP CONNECTORS OF CORRESPONDING SIZES AND TUBES MARKED AS PER (B)(4) SPECIFICATION. PRODUCTS FITTED WITH PVC BULLET VALVES WITH PILOT BALLOONS PRINTED WITH SIZES IDENTIFICATION 5.5MM AND WORK ORDER #: (B)(4). THE SAMPLES WERE TESTED ON (B)(4) 2014. THE SAMPLES WERE INSPECTED AND THE OBSERVATIONS ARE AS FOLLOWS: TWO UNITS CONFIRMED FOR BROKEN PRODUCT AND ONE UNIT CONFIRMED FOR HAIR IN PACKAGE. REVIEW OF THE ASSEMBLY RECORD DID NOT REVEAL ANY SIGNS OF THE ASSOCIATED DEFECTS DETECTED DURING THE 100% LIGHT TEST. BASED ON THE ANALYSIS OF THE RETURNED SAMPLES PROVIDED WAS INSPECTED AND FOUND NOT MEETING OUR INSPECTION CRITERIA. FOR THE HAIR IN PACKAGE ISSUE HAS BEEN INVESTIGATED PREVIOUSLY TO ADDRESS THE CONFIRMED COMPLAINT AND DOCUMENTED IN THE CAPA SYSTEM. HOWEVER, RELATED PERSONNEL WILL BE INFORMED FOR PRODUCT BROKEN ISSUE AND APPROPRIATE CORRECTIVE ACTION WILL BE TAKEN TO PREVENT FUTURE RECURRENCE OF SIMILAR TYPE OF DEFECTS. 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 INCOMING INSPECTION "FOUND PRODUCT BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276798 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61110055 614633R001

    Patients

    Seq Age Sex Outcome Treatment
    1