BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFIT CONNECTOR

    MDR report key: 7809341 · Received August 22, 2018

    Report

    Report Number
    MW5079333
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    June 18, 2018
    Report Date
    August 20, 2018
    Manufacturer
    HALYARD / AVANOS MEDICAL INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFORMED THAT PT'S FEEDING TUBE BROKE. THAT THE FEMALE PORT OF THE ENFIT FEEDING TUBE DISLODGED FROM THE FEEDING TUBE. PT'S FEEDING TUBE WAS REPLACED SECONDARY TO PREVIOUS FEEDING TUBE WAS BROKEN. TUBE WAS PLACED ON (B)(6) 2018 TO A 22 FRENCH MIC G TUBE 8100-22 BY IR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645524 ENFIT CONNECTOR TUBES, GASTROINTESTINAL AND ACCESSING KNT HALYARD / AVANOS MEDICAL INC.
    645525 MIC GASTROSTOMY FEEDING TUBE TUBES, GASTROINTESTINAL AND ACCESSING KNT HALYARD / AVANOS MEDICAL INC. 8100-22 AA8148D19

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention