BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F

    MDR report key: 10737536 · Received October 26, 2020

    Report

    Report Number
    3006260740-2020-03468
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KGC
    UDI-DI
    00801741080852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER WAS PROVIDED FOR THE REPORTED MALFUNCTION; THEREFORE, A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER PHOTOS WERE PROVIDED AND REVIEWED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED LEAK AND DEFORMATION ISSUES.A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION.THE DEVICE IS LABELED FOR SINGLE USE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000259 FEEDING TUBE ALLEGEDLY HAD FLUID LEAK AND DEFORMATION DUE TO COMPRESSIVE STRESS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A MALE PATIENT. AGE AND WEIGHT OF THE PATIENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED FOR THE REPORTED MALFUNCTION; THEREFORE, A LOT HISTORY REVIEW IS CURRENTLY BEING PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER PHOTO WAS PROVIDED. 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 000259 FEEDING TUBE ALLEGEDLY FLUID LEAK AND DEFORMATION DUE TO COMPRESSIVE STRESS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A MALE PATIENT. AGE AND WEIGHT OF THE PATIENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201982 BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F FEEDING TUBE KGC BARD ACCESS SYSTEMS 000259 HUDY1177 00801741080852

    Patients

    Seq Age Sex Outcome Treatment
    1