BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9FR J FEED/GASTRIC DEPR TUBE

    MDR report key: 3912355 · Received June 27, 2014

    Report

    Report Number
    9612030-2014-00035
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS MANUFACTURED ON 9/13/2013. THE DEVICE HISTORY RECORD (DHR) FILE WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE MANUFACTURE OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. A SAMPLE WAS RECEIVED FOR EVALUATION. AFTER A VISUAL INSPECTION THE ISSUE REPORTED WAS CONFIRMED, THE TUBE WAS FOUND DETACHED FROM THE BLUE VALVE. VISUAL INSPECTION WAS CONDUCTED IN ACCORDANCE TO PROCEDURE. ACCORDING TO THE SAMPLE EVALUATION, THE POTENTIAL ROOT-CAUSE THAT TRIGGERS THIS FAILURE MODE COULD BE PRODUCED IN THE FIELD DUE TO THE (B)(6) MARKET USING A SPECIFIC TYPE OF CONNECTOR FOR ENTERAL FEEDING. THIS CONNECTOR HAS A BIGGER DIAMETER WHICH DEFORMS AND EXPANDS THE INTERNAL DIAMETER OF THE Y-PORT. SINCE THE FAILURE WAS NOT RELATED TO THE MANUFACTURING PROCESS, A CORRECTIVE ACTION IN THE MANUFACTURING PROCESS IS NOT DEEMED NECESSARY AT THIS TIME. HOWEVER AS PART OF THE PROCESS IMPROVEMENTS FOR A SIMILAR FAILURE MODE, THE FOLLOWING ACTIONS WERE IMPLEMENTED. THE PRODUCTION PERSONNEL WERE NOTIFIED ABOUT THE CONDITION AND THE ACCEPTABLE QUALITY LEVEL (AQL) FOR SUB ASSEMBLY INSPECTION WAS MOVED FROM NORMAL TO TIGHTEN IN THE FUNCTIONAL INSPECTION. A QUALITY ALERT WAS POSTED IN THE LINE TO REINFORCE THE MANUAL ASSEMBLY AND TO BRING AWARENESS TO THE OPERATORS ABOUT THE MOST CRITICAL SECTIONS THAT MUST BE COVERED WITH ENOUGH THF. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE, THE CUSTOMER STATES THAT AFTER 5 DAYS OF USE, THE CATHETER FELL INTO THE SMALL INTESTINE. THE CATHETER WAS FOUND DETACHED FROM THE FEEDING PORT. THE ADHESION BETWEEN THE FEEDING PORT AND INNER FEEDING PORT CAME OFF AND THE CATHETER FELL INTO THE PATIENT. IT IS UNKNOWN THE EXACT REASON WHY THE CATHETER FELL INSIDE THE INTESTINE, BUT IT IS POSSIBLE THAT IT WAS CAUSED BY PERISTALSIS. IT WAS REMOVED WITH ENDOSCOPE ON THAT DAY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376297 9FR J FEED/GASTRIC DEPR TUBE FEEDING TUBE KNT COVIDIEN 8884750095 325590664X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other