BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD 2WAY SIL 5CC 14FR

    MDR report key: 4973619 · Received August 5, 2015

    Report

    Report Number
    8040412-2015-00168
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 13, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOT NUMBER 141139 PROVIDED IS NOT PRESENT IN SYSTEM, THEREFORE A DHR REVIEW COULD NOT BE CONDUCTED. THERE WAS NO SAMPLE RETURNED FOR INVESTIGATION. THEREFORE; INVESTIGATION WAS CONDUCTED BASED ON CURRENT PRODUCTION SAMPLES. CATHETERS PASSED THE REQUIREMENTS OF THE FUNCTIONALITY TEST. VISUAL INSPECTION CONDUCTED ON THE SAMPLES OBSERVED THERE WAS NO BURST OR CRACK FOUND ON THE BALLOONS. BASED ON INVESTIGATION CONDUCTED, PRODUCTION SAMPLES ARE FULLY FUNCTIONAL. THE BALLOONS WERE ABLE TO INFLATE AND DEFLATE WITHOUT ANY DIFFICULTIES FACED. FURTHERMORE, THE CATHETERS HAVE PASSED THE SOAK TEST, WHICH INDICATES NO LEAK OF WATER DURING CATHETERIZATION. THEN, THE CATHETERS ALSO HAVE PASSED REVERSE FLOW RATE TEST, WHICH INDICATES NO BLOCKAGE OF THE DRAINAGE LUMEN. NO OTHER ABNORMALITIES WERE OBSERVED. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOT NUMBER THAT WAS PROVIDED BY THE CUSTOMER IS UNKNOWN; THEREFORE, A DHR REVIEW COULD NOT BE CONDUCTED. ONE ACTUAL COMPLAINT SAMPLE WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION WAS CONDUCTED AND THE CATHETER WAS UNABLE TO EXPAND, BECAUSE THE BALLOON AREA WAS FLATTENED, AS IT HAD BEEN PRESSED WITH HEAVY OBJECT OR DUE TO EXCESSIVE ASPIRATION DURING CATHETER REMOVAL AND MANIPULATION. REVIEWING THE MANUFACTURING PROCESS, NO POTENTIAL CAUSE COULD HAVE CONTRIBUTED TO THE PROBLEM. ALL PRODUCTS WERE SUBJECTED TO 100% INSPECTION OF LEAK TEST, INFLATION, AND DEFLATION TEST. THE DEFECT RELATED TO FUNCTIONALITY OF THE PRODUCT WILL BE CULLED OUT DURING INSPECTION. BASED ON ANALYSIS CONDUCTED, THE RETURNED CATHETER COULD NOT INFLATE DUE TO THE BALLOON AREA INDENTATION. SINCE THERE WAS NO BLOCKAGE ISSUE OBSERVED BASED ON REPORTED FAILURE, THEREFORE; THIS COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE BALLOON FAILED TO DEFLATE WHEN IT WAS TIME TO REMOVE THE CATHETER; CUTTING THE SHAFT FAILED TO WORK AS WELL. THE PATIENT WAS REPOSITIONED AND THE CATHETER WAS MANIPULATED UNTIL ANOTHER STAFF MEMBER WAS ABLE TO ASPIRATE ENOUGH WATER THAT THE CATHETER WAS ABLE TO BE REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE BALLOON FAILED TO DEFLATE WHEN IT WAS TIME TO REMOVE THE CATHETER; CUTTING THE SHAFT FAILED TO WORK AS WELL. THE PATIENT WAS REPOSITIONED AND THE CATHETER WAS MANIPULATED UNTIL ANOTHER STAFF MEMBER WAS ABLE TO ASPIRATE ENOUGH WATER THAT THE CATHETER WAS ABLE TO BE REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE BALLOON FAILED TO DEFLATE WHEN IT WAS TIME TO REMOVE THE CATHETER; CUTTING THE SHAFT FAILED TO WORK AS WELL. THE PATIENT WAS REPOSITIONED AND THE CATHETER WAS MANIPULATED UNTIL ANOTHER STAFF MEMBER WAS ABLE TO ASPIRATE ENOUGH WATER THAT THE CATHETER WAS ABLE TO BE REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512471 GOLD 2WAY SIL 5CC 14FR FOLEY CATHETER FGH TELEFLEX MEDICAL 14I139

    Patients

    Seq Age Sex Outcome Treatment
    1