BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SET, 500ML, WITH ENFIT CONNECTOR

    MDR report key: 6021765 · Received October 12, 2016

    Report

    Report Number
    1722139-2016-00573
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    January 1, 2016
    Report Date
    January 20, 2016
    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
    MN, 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. (B)(4) 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, (B)(4) 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 (B)(4) 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.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THE ADMINISTRATION SET WAS CRACKING AND LEAKING AND THAT THE PATIENT MISSED A FEEDING AS WELL AS THE MEDICATION THEY USUALLY INCLUDE IN THIS FEEDING BECAUSE OF THE SET PROBLEM. NO INJURY TO A PATIENT WAS REPORTED, AND MMDG RECEIVED NO FURTHER INFORMATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675062 BAG SET, 500ML, WITH ENFIT CONNECTOR ENTERAL FEEDING SET PIO MOOG MEDICAL DEVICES GROUP INF0500-A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1