BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SET, 1200ML, WITH ENFIT CONNECTOR

    MDR report key: 6194524 · Received December 21, 2016

    Report

    Report Number
    1722139-2016-00622
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    PIO
    PMA / PMN Number
    K142539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MMDG HAS ATTEMPTED TO FOLLOW UP WITH THE INITIAL REPORTER TO OBTAIN THE BAG THAT MALFUNCTIONED. IT IS STILL UNCLEAR IF MMDG WILL RECEIVE THE AFFECTED SET BACK FOR INVESTIGATION. BECAUSE IT HAS NOT BEEN RETURNED AT THIS TIME, MMDG HAS BEEN UNABLE TO INVESTIGATE OR CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATES THAT THE "BAG DOES NOT DELIVER FOOD - PUMP DOESN'T ALARM." THEY REPORT THIS HAS RESULTED IN A COUPLE OF MISSED FEEDINGS WHILE THE PATIENT HAS BEEN AT SCHOOL. THERE HAVE BEEN NO ADVERSE EFFECTS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843155 BAG SET, 1200ML, WITH ENFIT CONNECTOR ENTERAL FEEDING SET PIO MOOG MEDICAL DEVICES GROUP INF1200-A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR