BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVITY-FED BAG SET, 1200ML, WITH ENFIT CONNECTOR

    MDR report key: 5494329 · Received March 11, 2016

    Report

    Report Number
    1722139-2016-00256
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    PIO
    PMA / PMN Number
    K142539
    Removal / Correction Number
    1722139-11/19/15-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS NEW TO THE MARKET. IT IS ONE OF THE FIRST ENTERAL BAG/ADMINISTRATION SETS TO INCORPORATE THE NEW ENFIT CONNECTORS, WHICH WERE SPECIFICALLY DESIGNED TO BE EXCLUSIVELY COMPATIBLE WITH ENTERAL FEEDING TUBES. MOOG IS ONE OF THE FIRST COMPANIES TO BRING ENFIT CONNECTOR-CONTAINING PRODUCTS TO THE MARKET, BUT OTHERS WILL SHORTLY FOLLOW SUIT. IN FACT, THE ENFIT CONNECTORS ARE SCHEDULED TO BECOME THE INDUSTRY STANDARD OVER THE COURSE OF 2015, WITH THE OLDER CHRISTMAS-TREE-STYLE CONNECTORS SCHEDULED TO BE PHASED OUT OF THE INDUSTRY BY EARLY 2016. SINCE THE INTRODUCTION OF THE NEW ENFIT CONNECTOR-CONTAINING ENTERAL FEEDING SETS EARLIER THIS YEAR, MOOG HAS RECEIVED A NUMBER OF COMPLAINTS ABOUT THE NEW SETS, THE MOST COMMON BEING THAT THEY LEAK IN THE VICINITY OF THE PURPLE ENFIT CONNECTOR PIECE AND THE WHITE TRANSITIONAL STEPPED CONNECTOR. NO INJURY TO A PATIENT WAS ALLEGED IN THIS PARTICULAR COMPLAINT, AND MOOG HAS NOT RECEIVED ANY ADDITIONAL INFORMATION INDICATING THAT A PATIENT WAS OR MAY HAVE BEEN HARMED AS A RESULT OF THE REPORTED EVENT. MOOG WOULD NOT NORMALLY SUBMIT AN MDR FOR THIS EVENT, BUT IS DOING SO NOW BECAUSE THIS PARTICULAR ISSUE (LEAKY ENFIT CONNECTOR) HAS CAUSED A REPORTABLE INJURY TO A PATIENT WITHIN THE LAST TWO YEARS. THE COMPLAINANT DID NOT RETURN THE AFFECTED SETS FOR EVALUATION. MMDG WILL CEASE PRODUCTION OF ALL ITS ENTERAL ADMINISTRATION SETS USING ENFIT CONNECTORS AND TRANSITION BACK TO THE PREVIOUS REVISION OF THE PRODUCT CODES THAT DO NOT INCLUDE THE ENFIT CONNECTOR (INF0020, INF0500, INF1200 AND GR1200). THE PREVIOUS REVISION INCLUDES NEITHER THE ENFIT CONNECTOR NOR THE TRANSITIONAL CONNECTOR. THIS REVISION DOES NOT EXHIBIT THE SAME DEGREE OF LEAKING, NOR HAS IT EXPERIENCED ANY ADVERSE REACTION TO FORMULA INGREDIENTS. MMDG WILL PRODUCE THE PREVIOUS REVISION UNTIL A SUITABLE SOLUTION TO THE ENFIT CONNECTOR MATERIAL DEGRADATION PROBLEM IS FOUND.

    Description of Event or Problem · 1

    AS RECORDED BY CUSTOMER SERVICE: "NEW ENFIT CONNECTOR DOES NOT HAVE TIGHT FIT IN G TUBE." NO INJURY TO A PATIENT WAS REPORTED, AND NO FURTHER DETAILS WERE PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151639 GRAVITY-FED BAG SET, 1200ML, WITH ENFIT CONNECTOR ENTERAL ADMINISTRATION SET PIO MOOG MEDICAL DEVICES GROUP GR1200-A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPLENA W/ RENVELA