BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3960542 · Received June 24, 2014

    Report

    Report Number
    9611710-2014-00148
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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. IT WAS FURTHER REPORTED THE PRODUCT WAS NOT USED ON A PATIENT. ADD'L INFO WAS REQUESTED. NOTE: ISSUE OCCURRED ON 17 SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER 16 CASES. 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 THE COMPLAINANT STATED "DURING INCOMING INSPECTION FOUND PACKAGE TORN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368078 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 61130040 614196R001

    Patients

    Seq Age Sex Outcome Treatment
    1