BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3950777 · Received June 9, 2014

    Report

    Report Number
    9611710-2014-00140
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADD'L INFO WAS REPORTED VIA EMAIL ON (B)(6) 2014 THAT THE PT WAS NOT INJURED BY PRODUCT AND THE SAME ENDOTRACHEAL WAS USED AFTER ADDING STOPCOCK (DID NOT CHANGE TO NEW TUBE). A QUALITY EVAL WAS PERFORMED ON (B)(4) 2014. BASED ON THE PRODUCT CODE INFO PROVIDED, THE RELATED ASSEMBLY BATCH RECORD WAS RETRIEVED FOR REVIEW. BASED ON THE PRODUCT LOT NUMBER PROVIDED BY CUSTOMER, THE ASSEMBLY WORK ORDER WAS RETRIEVED TO ASSIST IN INVESTIGATION. REVIEW OF ASSEMBLY BATCH RECORD REVEALED THAT THERE IS (B)(4) OF LEAK AT BALLOON AND (B)(4) OF LEAK AT PILOT BALLOON WAS DETECTED AND THE DEFECTIVE TUBES WERE REJECTED AND DISCARDED. TREND ANALYSIS FOR THE CUFF LEAKAGE, PILOT BALLOON LEAK AND TOM CUFF INCLUDING INPROCESS AND OUTGOING BASED ON THE BATCH RECORDS FOR THIS PARTICULAR PRODUCT (35215) FOR THE PAST (B)(4). BASED ON THE LEAK TREND FOR THE PAST (B)(4) DATA ABOVE, IT COULD BE SEEN THAT LEAK PRODUCTS HAD BEEN DETECTED AND SEGREGATED DURING 100% INSPECTION IN PRODUCTION STAGE, WHICH WAS REFLECTED IN OUTGOING RESULTS WHERE NO LEAK WAS FOUND WHILST FOR THE TOM CUFF TREND, IT COULD BE SEEN THAT THERE IS NO TOM CUFF DETECTED DURING 100% INSPECTION IN PRODUCTION STAGE, WHICH WAS ALSO REFLECTED IN OUTGOING RESULTS. REVIEW OF THE RISK ASSESSMENT FILE DOES COVER POTENTIAL CAUSES AND IT'S CONTROLLED. REVIEW OF THE COMPLAINT TREND WITHIN YEAR 2009 TO 2013 FOR THE LEAK/TORN CUFF ISSUE, STATISTICALLY THERE IS SIGNIFICANT POSITIVE TRENDING WAS OBSERVED AS THERE IS A REDUCTION IN COMPLAINT CPM OVER THE YEARS. BASED ON THE PICTURE OF THE DEFECTIVE SAMPLE AND THE EVAL RESULT FROM OUR LABORATORY STATING: THE BALLOON WAS FILLED WITH 5 CC'S OF WATER. LEAKAGE WAS OBSERVED IN THE AREA OF THE CUFF. WHEN VIEWED UNDER MAGNIFICATION, THE CUFF IS RUPTURED. BASED ON THE PICTURE PROVIDED, IT IS UNLIKELY THAT SUCH DEFECT COULD HAVE PASSED THE 100% INSPECTION AFTER LEAK TEST. THE BALLOON FOR THE TUBE WAS SUPPLIED BY THE SUPPLIER (CUSTOMER SUPPLIED PRODUCT). THEREFORE, NO TESTING WAS PERFORMED AT INCOMING. PARTS WERE RELEASED BASED ON CERTIFICATE OF ANALYSIS. BASED ON LEAK/TORN CUFF AND COMPLAINT TRENDING ANALYSIS, DID NOT SHOW ANY SIGNIFICANT ABNORMALITIES. THE CURRENT PROCESS CONTROL REQUIRES THAT ALL ET TUBES ARE INFLATED TO DETERMINE THAT THE BALLOON IS LEAK/BURST FREE. THUS, THERE IS A HIGH DEGREE OF ASSURANCE THAT THE PRODUCT IF FULLY FUNCTIONAL WHEN SHIPPED. BASED ON PICTURE PROVIDED, WE COULD NOT REALLY DETERMINE THE CAUSE FOR SUCH A BIG CUFF TORN, ESPECIALLY WITH 100% INFLATION/DEFLATION TEST AS WELL AS VISUAL INSPECTION. WE ANTICIPATE THE TORN COULD HAVE BEEN INDUCED DURING PRODUCT USAGE, I.E. CUFF CONTACTED WITH SHARP OBJECT SUCH AS LARYNGOSCOPE ETC. THUS, NO FURTHER EVAL NEEDED AND COMPLAINT CAN BE CONSIDERED CLOSED. NO ADD'L PT/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 "ER PHYSICIAN TESTED CUFF PRIOR TO INTUBATION. AFTER INTUBATION NOTICED THAT HE WAS NOT ABLE TO MAINTAIN CUFF PRESSURE." A RESPIRATORY THERAPIST ON SITE SUGGESTED USING A 3 WAY STOP COCK ON THE BALLOON VALVE WHICH APPEARED TO SOLVE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335044 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35215 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1