BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPAT

    MDR report key: 5491632 · Received March 10, 2016

    Report

    Report Number
    5491632
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    February 15, 2016
    Report Date
    March 7, 2016
    Manufacturer
    NESTLE HEALTHCARE NUTRITION INC
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE WENT TO HANG A NEW BAG OF TUBE FEEDING ON HIS PATIENT. WHEN HE TRIED TO SPIKE THE BAG, THE "SPIKE" NEVER PIERCED THE BAG AND THE ADAPTER PORTION TORE AWAY FROM THE BAG ITSELF. NEW BAG OF TUBE FEED HAD TO BE OBTAINED AND VERY LITTLE DELAY IN PATIENT TREATMENT OCCURRED. MANUFACTURER RESPONSE FOR 1.5 TUBE FEEDING BAG, 1.5 CAL (PER SITE REPORTER): THEY ARE SENDING ME SHIPPING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148818 COMPAT TUBE, FEEDING FPD NESTLE HEALTHCARE NUTRITION INC 02970

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES