BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRFLX 12FR;43IN W/STYL YPOR

    MDR report key: 11473414 · Received March 12, 2021

    Report

    Report Number
    9612030-2021-02810
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Report Date
    August 19, 2021
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    UDI-DI
    10884521583030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THERE WAS NO PHYSICAL SAMPLE AVAILABLE FOR THE EVALUATION. FEW PICTURES WERE PROVIDED FOR THE EVALUATION. ONE PICTURE SHOWS A BROKEN Y-PORT. A REVIEW THROUGH THE MANUFACTURING PROCESS WAS CONDUCTED. IN GENERAL, ALL PROCESS AND CONTROLS WERE FOUND PROPERLY FOLLOWED, INCLUDING SUB-ASSEMBLIES, FINISHED PRODUCT ASSEMBLY AND PACKAGING AND INSPECTIONS PERFORMED TO THE PRODUCT. THERE WERE NO ABNORMAL CONDITIONS FOUND THAT COULD TRIGGER THE REPORTED CONDITION. PER THE INVESTIGATION RESULTS, NO ROOT CAUSE COULD BE FOUND RELATED TO MANUFACTURING/PRODUCTION PROCESS. MOST LIKELY ROOT CAUSE FOR THE BROKEN Y-PORT WAS FOUND DUE TO A USER MISUSE BY INADEQUATELY FORCING THE EXTRACTION OF THE ADAPTER; HOWEVER, A CLOGGED CONDITION AND A TUBING CONNECTION ISSUE COULD NOT BE CONFIRMED THROUGH THE PICTURES ALONE. A PHYSICAL SAMPLE IS REQUIRED TO EXAMINE AND CONFIRM QUALITY SPECIFICATIONS. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE SAMPLE IS RETURNED, THIS FILE WILL BE RE-OPENED FOR FURTHER INVESTIGATION. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. THE CURRENT PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS, MEETING ALL QUALITY ACCEPTANCE CRITERIA. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    SECTION E1: FACILITY NAME, ADDRESS AND CONTACT NUMBER FIELD HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FEEDING TUBE IS GETTING VERY CLOGGED, SO THAT IT IS REQUIRED TO CHANGE THEM EVERY 24 HOURS, WHICH IMPLIES RADIATING THE PATIENT AND BOTHERING THEM. THE CUSTOMER FURTHER STATED THAT IN ADDITION TO CLOGGING, IT RENDERS THE CONNECTIONS UNSTABLE AND ONCE THE FEEDING TUBE GET IN CONTACT WITH THE NUTRITION, THEY ARE IMPOSSIBLE TO OPEN. THE CONNECTION BY WHICH THE NEW FEEDING EQUIPMENT CONNECTS REMAINS STUCK AND WHEN THE CUSTOMER TRIES TO SEPARATE THEM WITH A MOSQUITO (A BLUNT-TIPPED CLIP USED TO HOLD THE PROBE TO TRY TO UNSCREW THE CAP), IT ENDED UP BREAKING THE Y-CONNECTION, WHICH IMPLIES THE CHANGING OF PROBE AGAIN. THERE WAS NO LEAKING OBSERVED. THE NUTRITION USED IS MOSTLY FROM ABBOTT (PROMOTE, GLUCERNA, ENSURE) AND WHEN THE NUTRITION GETS IN CONTACT WITH THE PROBES IT HARDENS, AS IF IT WERE GLUE. THE CUSTOMER ALSO MENTIONED THAT IF THEY USE NESTLÉ NOVASOURCE NUTRITION, THESE PROBLEMS ARE NOT HAPPENING. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367152 ENTRFLX 12FR;43IN W/STYL YPOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT COVIDIEN 8884721252E 1903611964 10884521583030

    Patients

    Seq Age Sex Outcome Treatment
    1