BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3902467 · Received May 7, 2014

    Report

    Report Number
    9611710-2014-00097
    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 INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. AN EVALUATION WAS PERFORMED ON (B)(4) 2014. RECEIVED EIGHT UNUSED I.D 7.0MM, CATALOG#: 61110070 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 7.0 MM AND WORK ORDER #: (B)(4). THE PRODUCTS WERE REC'D IN SEALED (B)(4) PREPRINTED BLISTER PACK AND AFFIXED WITH LABEL. THE SAMPLES WERE INSPECTED AND THE OBSERVATIONS ARE AS FOLLOWS: ONE UNIT CONFIRMED FOR FOREIGN SUBSTANCE IN PACKAGE, WHEREAS ONE UNIT WAS SHOWN TO HAVE NO SIGNS OF FOREIGN SUBSTANCE IN PACKAGE; TWO UNITS WERE CONFIRMED FOR HAIR IN PACKAGE; ONE UNIT CONFIRMED FOR STAIN ON PRODUCT AND THREE UNITS WERE CONFIRMED FOR BROKEN PRODUCT. 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 IT WAS FOUND THAT SEVEN OUT OF EIGHT UNITS RETURNED WERE NOT MEETING OUR INSPECTION CRITERIA. HOWEVER, THIS COMPLAINT ISSUE HAS BEEN INVESTIGATED TO ADDRESS THE CONFIRMED COMPLAINT AND DOCUMENTED IN THE CAPA SYSTEM. NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INCOMING INSPECTION "FOUND CONTAMINATION ON PACKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276854 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61110070 615508R001

    Patients

    Seq Age Sex Outcome Treatment
    1