BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUAL-FLOW GASTRIC TUBE

    MDR report key: 2034713 · Received March 21, 2011

    Report

    Report Number
    2245270-2011-00014
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 21, 2011
    Manufacturer
    VYGON SA
    Product Code
    KNT
    PMA / PMN Number
    K860285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT REPORT WAS SENT TO VYGON FRANCE FOR INVESTIGATION. RESULTS OF THIS INVESTIGATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    AN 8FR SUMP TUBE WAS BEING USED ON A PREMATURE INFANT. THE TUBE WAS PLACED TOO DEEP AND PERFORATED THROUGH THE STOMACH, GOING INTO THE PERITONEAL CAVITY. THE STOMACH WAS REPAIRED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL-FLOW GASTRIC TUBE GASTROINTESTINAL TUBE KNT VYGON SA 1340.08 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention