BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10737564 · Received October 26, 2020

    Report

    Report Number
    3006260740-2020-03467
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Report Date
    October 26, 2020
    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 · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A LOT HISTORY REVIEW COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION; THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE FOR LOW FLOW RATE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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 GASTRO-ENTEROSTOMY TUBE ALLEGEDLY EXPERIENCED RESTRICTED FLOW RATE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202443 BARD BUTTON DEVICE BOLUS FEEDING TUBE WITH STRAIGHT ADAPTOR, 24F GASTRO-ENTEROSTOMY TUBE KGC BARD ACCESS SYSTEMS 000259 UNKNOWN 00801741080852

    Patients

    Seq Age Sex Outcome Treatment
    1