BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING SET

    MDR report key: 2132585 · Received June 10, 2011

    Report

    Report Number
    1722139-2011-00095
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    KNT
    PMA / PMN Number
    K037799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE A LOT # FOR THE DEVICE. WITHOUT THE LOT NUMBER, THE EXPIRATION DATE (D4) AND DATE OF MANUFACTURE CANNOT BE DETERMINED. THE DEVICE(S) HAS NOT BEEN RETURNED. WITHOUT THE LOT NUMBER, THE EXPIRATION DATE AND DATE OF MANUFACTURE CANNOT BE DETERMINED. AN EVALUATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER STATED THE BAG SET WAS LEAKING. THE MALFUNCTION CAUSED A DELAY IN THERAPY. PATIENT INJURY? YES, THE PATIENT'S MOTHER STATED HER SON WAS HOSPITALIZED FOR ANOTHER REASON BUT NOT FOR THIS ISSUE (PLANNED GI). THE PATIENT REQUIRES CONTINUOUS FLUIDS FOR 20 TO 22 HOURS A DAY. THE DELAY CAUSED THE PATIENT TO LOSE EXECUTIVE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING SET KNT MOOG MEDICAL DEVICES GROUP INF1200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention