BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-FUNNEL REPL GAST 20F

    MDR report key: 8808150 · Received July 19, 2019

    Report

    Report Number
    3006260740-2019-02064
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Report Date
    October 2, 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 DEVICE IS RETURNED TO BD FOR EVALUATION. THE INVESTIGATION IS CONFIRMED FOR A BALLOON LEAK. IN ADDITION, TWO ELECTRONIC PHOTOS WERE PROVIDED FOR REVIEW. THE PICTURED TRIFUNNEL DEVICE APPEARS TO HAVE A BURST AND DISCOLORED BALLOON IN BOTH CASES. THE INTERIOR BALLOON MATERIAL APPEARS MORE DISCOLORED THAN THE OUTER. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICE WAS LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000720. FEEDING TUBE WAS ALLEGEDLY EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR THE ONE COMPLAINT. THE PHOTO REVIEW IS CURRENTLY UNDERWAY REVIEW. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000720. FEEDING TUBE WAS ALLEGEDLY EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603459 TRI-FUNNEL REPL GAST 20F FEEDING TUBE KNT BARD ACCESS SYSTEMS 000720 UNKNOWN 00801741037153

    Patients

    Seq Age Sex Outcome Treatment
    1