BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F

    MDR report key: 8529940 · Received April 18, 2019

    Report

    Report Number
    3006260740-2019-01027
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KGC
    UDI-DI
    00801741080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE EVENT IS UNKNOWN, THEREFORE THE MANUFACTURING REVIEW COULD NOT BE CONDUCTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR FRACTURE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 000256 FEEDING DEVICE EXPERIENCED A FRACTURE. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS REPORTED AS A (B)(6)-YEAR-OLD FEMALE WEIGHING (B)(6) LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319356 BARD BUTTON DEVICE CONTINUOUS FEEDING TUBE WITH 90° ADAPTER 18F FEEDING DEVICE KGC BARD ACCESS SYSTEMS 000256 UNKNOWN 00801741080821

    Patients

    Seq Age Sex Outcome Treatment
    1