BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERITUS ENTRAL

    MDR report key: 6893446 · Received September 26, 2017

    Report

    Report Number
    6893446
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 30, 2017
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAVE RECEIVED 3 PRODUCT COMPLAINTS FROM OUR NICU THAT THE TAB TO OPEN THE CAP KEEPS BREAKING OFF, WHICH CAUSES THEM TO HAVE TO REMOVE THE TUBE AND INSERT A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675420 AMERITUS ENTRAL TUBE, FEEDING FPD KENTEC MEDICAL, INC. AEG-40P-50 602103

    Patients

    Seq Age Sex Outcome Treatment
    1