BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GJ 16R/45CM 3.0 STOMA AVANOS/ MIC-GASTRIC-JEJUNAL FEEDING TUBE

    MDR report key: 9681995 · Received February 6, 2020

    Report

    Report Number
    MW5092842
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    October 19, 2019
    Report Date
    February 4, 2020
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EVENT INVOLVES PROBLEM WITH MIC-GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTORS-ENDOSCOPIC/RADIOGRAPHIC PLACEMENT. THIS REPORT IS ANOTHER EXAMPLE OF COMPLICATIONS ARISING FROM RISK OF ENFIT PRODUCTS BECOMING STUCK LEADING TO NEED FOR SUBSEQUENT TREATMENT/PROCEDURES. PT WITH FRESHLY PLACED GJ TUBE WITH ENFIT CONNECTIONS. JT PORT BECAME STUCK AND WAS DIFFICULT TO MANIPULATE. EVENTUALLY STAFF WAS ABLE TO "UNSTUCK" THE TUBING BUT IN THE PROCESS THE INTERNAL ENFIT CONNECTION ON THE J PORT WAS BROKEN. THE PT IS POST PANCREATECTOMY WITH A NEW INSULIN REQUIREMENT SO STABLE GIR IS CRUCIAL. THE PT HAD TO GO BACK TO THE OPERATING ROOM FOR A SEDATED PROCEDURE TO HAVE GJ TUBE REPLACED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142783 GJ 16R/45CM 3.0 STOMA AVANOS/ MIC-GASTRIC-JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 8250-16

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention