BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERAL FUNNEL ENFIT TRANSITION CONNECTOR WITH CAP

    MDR report key: 19142890 · Received April 18, 2024

    Report

    Report Number
    MW5153998
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 16, 2024
    Manufacturer
    CEDIC S.R.L.
    Product Code
    PIO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A G-TUBE (GASTROSTOMY TUBE) REPLACED ON (B)(6) 2024. A TRANSITION CONNECTOR WAS PROVIDED TO THE FAMILY TO USE AT HOME. ON (B)(6) 2024, FAMILY CALLED STATING THAT THE CONNECTOR WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583377 ENTERAL FUNNEL ENFIT TRANSITION CONNECTOR WITH CAP ENTERAL SPECIFIC TRANSITION CONNECTORS PIO CEDIC S.R.L. 02112018

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other GASTROSTOMY TUBE.