BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3894565 · Received May 2, 2014

    Report

    Report Number
    9611710-2014-00088
    Event Type
    Malfunction
    Date Received
    May 2, 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

    AN EVALUATION WAS PERFORMED ON (B)(4) 2014. RECEIVED SEVENTEEN UNUSED I.D. 7.5MM, CATALOG NUMBER 61110075 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 7.5 MM AND WORK ORDER (B)(4). THE SAMPLES WERE TESTED ON (B)(4) 2014. THE SAMPLES WERE INSPECTED AND THE OBSERVATIONS ARE AS FOLLOWS: FOUR UNITS RETURNED SHOWED NO SIGNS OF FOREIGN SUBSTANCE IN PACKAGE, WHERE AS ONE UNIT WAS CONFIRMED FOR FOREIGN SUBSTANCE IN PACKAGE AND TWELVE UNITS CONFIRMED FOR STAIN ON 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 THIRTEEN OUT OF SEVENTEEN 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 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 STAIN ON PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265872 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61110075 615278R001

    Patients

    Seq Age Sex Outcome Treatment
    1