BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY TUBES -AIRWAY MANAGEMENT

    MDR report key: 4152294 · Received October 2, 2014

    Report

    Report Number
    9611710-2014-00306
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 15, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    JOH
    PMA / PMN Number
    K945874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PER THE INFO RECEIVED, THERE ARE A TOTAL OF SIX UNUSED PRODUCTS TO BE RETURNED. ADDITIONAL INFO HAS BEEN REQUESTED, HOWEVER NO EVENT DETAILS HAVE BEEN RECEIVED TO DATE. AN ANALYSIS ON THE RETURNED SAMPLES PROVIDES WAS MEASURED AND DID NOT PERFORM TO OUR REQUIREMENT BASED ON THE EVALUATION WHERE THE CURVATURE OF THE TUBE WAS FOUND NOT WITHIN SPECIFICATION. BASED ON THE INVESTIGATION, THE COMPLAINT ISSUE HAS BEEN FEED BACK TO OUR MANUFACTURING PERSONNEL AND CORRECTIVE ACTION HAS BEEN ASSESSED AS PART OF THE TRACKWISE RECORD. AN INVESTIGATION WAS PERFORMED THAT CONSISTED OF A REVIEW OF THE ASSEMBLY RECORD WHICH INDICATED 0.7% BENDING WAS DETECTED DURING THE INSPECTION PROCESS. THESE DEFECTIVE PARTS WERE REJECTED AND DISCARDED. A REVIEW OF THE RISK ASSESSMENT FILE DOES COVER POTENTIAL CAUSE AND IT'S CONTROLLED. A REVIEW OF THE COMPLAINT TREND WAS PERFORMED FROM 2009 TO YTD AUGUST 2014 WITH NOT SIGNIFICANT NEGATIVE TREND OBSERVED. NO ADDITIONAL INFO HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TUBAL ANGLE WAS FOUND TOO STRAIGHT TO USE BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614029 TRACHEOSTOMY TUBES -AIRWAY MANAGEMENT TUBE TRACHEOSTOMY AND TUBE CUFF, 73 JOH UNOMEDICAL SDN BHD MM62540080 544905R001

    Patients

    Seq Age Sex Outcome Treatment
    1