BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12FR X 68CM ENDOVIVE TTP JEJUNAL FEEDING PIGTAIL TIP

    MDR report key: 16435150 · Received February 24, 2023

    Report

    Report Number
    16435150
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT STATUS POST GJ (GASTROSTOMY-JEJUNOSTOMY) TUBE PLACEMENT ON [REDACTED DATE] IN CAE. [REDACTED DATE] - DUE TO GJ TUBE BEING CLOGGED, PATIENT S/P REPLACEMENT GJ TUBE REPLACEMENT IN CAE. [REDACTED DATE] - DUE TO EXTERNAL TUBING OF G TUBE NO LONGER BEING ATTACHED TO THE ADAPTER, PATIENT S/P GJ TUBE REPLACEMENT IN CAE [REDACTED DATE] - LEAK FROM ADAPTER WHICH APPEARS TO BE A DEFECT IN PLASTIC [REDACTED DATE] - GI TEAM APPLIED DERMABOND TO ADAPTER. UNKNOWN AS OF YET WHETHER THIS HAS FIXED THE LEAK. CONCERN FOR PRODUCT MALFUNCTION/DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947046 12FR X 68CM ENDOVIVE TTP JEJUNAL FEEDING PIGTAIL TIP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC CORPORATION LOG2359435 30674370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown