BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEEDING TUBE VALVE

    MDR report key: 9902926 · Received March 31, 2020

    Report

    Report Number
    9902926
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    February 13, 2020
    Report Date
    February 19, 2020
    Manufacturer
    ICU MEDICAL INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW CORTRAK 10 FR FEEDING TUBE INSERTED INTO THIS PT. THE VALVE DID NOT FIT SECURELY INTO THE FEEDING TUBE AND WOULD NOT STAY CONNECTED TO THE FEEDING TUBE, SO NURSE WAS UNABLE TO GIVE MEDS OR FEEDING THROUGH THIS AS USUAL. THE VALVE CHANGED TO LOT NUMBER 4142426, AND THIS ONE DID STAY SECURED AND WAS ABLE TO BE USED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369164 FEEDING TUBE VALVE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ICU MEDICAL INC 4130737

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA