BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING SET

    MDR report key: 2090807 · Received May 2, 2011

    Report

    Report Number
    1722139-2011-00082
    Event Type
    Other
    Date Received
    May 2, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 2, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    KNT
    PMA / PMN Number
    K037799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) HAS NOT BEEN RETURNED. THE COMPLAINANT IS UNABLE TO PROVIDE A LOT NUMBER FOR THE DEVICE. WITHOUT THE LOT NUMBER, THE EXP DATE AND DATE OF MANUFACTURE CANNOT BE DETERMINED. AN EVAL CANNOT BE PERFORMED. NO CLINICAL INJURY TO PT.

    Description of Event or Problem · 1

    PT MOTHER NOTICED A NO FLOW IN ALARM AND FOUND THAT THERE WERE STOMACH CONTENTS INSIDE OF THE FEEDING BAG. THE TUBING SET WAS REVERSED. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING SET KNT MOOG MEDICAL DEVICES GROUP INF0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR