BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAG SET, 500ML, ENFITCONNECTOR

    MDR report key: 11675167 · Received April 15, 2021

    Report

    Report Number
    1722139-2021-00292
    Event Type
    Death
    Date Received
    April 15, 2021
    Date of Event
    March 24, 2021
    Report Date
    March 24, 2021
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    PIO
    PMA / PMN Number
    K142539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MMDG FOR EVALUATION. A DHR COULD NOT BE COMPLETED BECAUSE NO LOT NUMBER WAS PROVIDED. BECAUSE THE DEVICE WAS NOT RETURNED, MMDG HAS BEEN UNABLE TO INVESTIGATE THE COMPLAINT. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. BASED ON THE INFORMATION PROVIDED TO MMDG THE PUMP AND ADMINISTRATION SET APPEAR TO HAVE BEEN PERFORMING AS EXPECTED. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE PATIENTS DEATH.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATES THAT THE PATIENT WAS TANGLED IN THE TUBING AND WAS STRANGLED. THEY ADVISED THAT THEY HAD CONNECTED THE ADMINISTRATION SET TO THE PATIENTS FEEDING TUBE AND THEN LEFT THE PATIENT ALONE FOR APPROXIMATELY TEN MINUTES WITH THE FEEDING RUNNING. WHEN THEY RETURNED THEY STATE THAT THE TUBING WAS WRAPPED AROUND THE PATIENTS NECK TWICE AND THAT THE PATIENT WAS NOT RESPONSIVE. THEY ATTEMPTED RESUSCITATION AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE INITIAL REPORTER STATED THAT THE PATIENT WAS PRONOUNCED BRAIN DEAD AND THAT LIFE SUPPORT WAS REMOVED. [COMPLAINT-(B)(4)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567383 BAG SET, 500ML, ENFITCONNECTOR ENTERAL FEEDING SET PIO MOOG MEDICAL DEVICES GROUP INF0500-A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Death