BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-FUNNEL REPL GAST 20F

    MDR report key: 8528415 · Received April 18, 2019

    Report

    Report Number
    3006260740-2019-00966
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT# WAS PROVIDED FOR BOTH DEVICES AND LOT HISTORY REVIEWS WERE PERFORMED. TWO 20FR TRI-FUNNEL REPLACEMENT TUBES WERE RETURNED FOR EVALUATION, FUNCTIONAL AND VISUAL EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS UNCONFIRMED FOR 2907J - ADAPTOR DETACHMENT, AS THE DEVICES FUNCTIONED PROPERLY UNDER LABORATORY CONDITIONS AND THE REPORTED EVENT COULD NOT BE REPRODUCED. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. THE DEVICE WAS LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE EVENT INDICATED THAT MODEL 000720 TRI-FUNNEL REPLACEMENT GASTRONOMY TUBES 20F EXPERIENCED AN ALLEGED DETACHMENT OF DEVICE. THE DEVICES WERE USED ON THE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT¿S AGE, SEX, AND WEIGHT WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 000720 TRI-FUNNEL REPLACEMENT GASTRONOMY TUBE 20F EXPERIENCED DETACHMENT OF DEVICE. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, SEX, AND WEIGHT WERE NOT PROVIDED. THE 000720 TRI-FUNNEL REPLACEMENT GASTRONOMY TUBE 20F WILL BE RETURNED FOR EVALUATION AND IS PENDING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322590 TRI-FUNNEL REPL GAST 20F FEEDING DEVICE KNT BARD ACCESS SYSTEMS 000720 NGCQ4383 00801741037153

    Patients

    Seq Age Sex Outcome Treatment
    1