BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS

    MDR report key: 7809318 · Received August 22, 2018

    Report

    Report Number
    MW5079330
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 20, 2018
    Manufacturer
    HALYARD / AVANOS MEDICAL INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTIFIED THAT PT'S TUBE REQUIRED REPLACEMENT TODAY (B)(6) 2018 BY IR WITH A 22 FR G TUBE SECONDARY #1. THE CAP WAS NOT CLOSING #2. THERE WERE TWO PIN HOLES IN THE DISTAL END OF THE TUBE NEAR THE CONNECTOR PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645512 MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS ENFIT G-TUBE FPD HALYARD / AVANOS MEDICAL INC. 8100-22 AA8148D19

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention