BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTRONOMY TUBE 18F

    MDR report key: 4232779 · Received September 12, 2014

    Report

    Report Number
    1417592-2014-00083
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DAY AFTER THE G-TUBE HAD BEEN REPLACED, THE DEVICE WAS FOUND TO BE DISLODGED FROM THE STOMA. NO INJURY RESULTED FOR THE RESIDENT AND A NEW G-TUBE WAS INSERTED. THE SAMPLE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION REVEALED THERE WAS A CLEAN TEAR ALONG THE LENGTH OF THE BALLOON. THE CAUSE OF THE TEART WAS NOT DETERMINED. EXPERIMENTALLY IT HAS BEEN SHOWN THAT OVER-INFLATION OF THE BALLOON CAN LEAD TO RUPTURE. WE CANNOT RULE OUT THE POSSIBILITY THAT THE BALLOON MAY HAVE BEEN OVER-INFLATED AFTER IT WAS INSERTED. NO OTHER ABNORMALITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE GASTROSTOMY TUBE FELL OUT AND A TEAR WAS NOTED IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564581 GASTRONOMY TUBE 18F KNT MEDLINE INDUSTRIES, INC. S14230435

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other