BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT

    MDR report key: 5343084 · Received January 5, 2016

    Report

    Report Number
    5343084
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    September 20, 2015
    Report Date
    November 12, 2015
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TUBE FEEDING BAG CAME APART JUST BELOW THE PUMP "DROPLET" PORT, TUBING HAS A JAGGED EDGE. UNFORTUNATELY, THE BAG AND PACKAGING WERE NOT SAVED. IT WAS NEW OUT OF THE PACKAGE AND WAS NOT USED AS IT CAME APART. THERE WAS NO HARM TO PATIENT AS IT WAS NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4752 COMPAT TUBE, FEEDING FPD NESTLE HEALTHCARE NUTRITION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1