BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO GASTROSTOMY TUBE

    MDR report key: 87175 · Received April 24, 1997

    Report

    Report Number
    1528738-1997-00021
    Event Type
    Injury
    Date Received
    April 24, 1997
    Date of Event
    March 8, 1997
    Report Date
    April 23, 1997
    Manufacturer
    ABBOTT LABORATORIES, ROSS PRODUCTS DIV.
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 3/8/97, THE BALLOON PORT (VALVE) OF THE DEVICE HAD FALLEN OUT OF THE DEVICE. THE BALLOON WAS DEFLATED. A NEW 20 FR G-TUBE WAS INSERTED WITHOUT DIFFICULTY. NO GASTRIC ASPIRATE OBTAINED. WATER WOULD NOT FLOW FREELY. THE BALLOON WAS DEFLATED AND THE TUBE WAS REINSERTED FURTHER. WATER FLOWED SLOWLY. THE PT REPORTED DISCOMFORT AND WAS SENT TO THE HOSP ER. THE PT WAS CHECKED BY THE ATTENDING PHYSICIAN WHO ATTEMPTED TO INSERT THE G-TUBE WITHOUT SUCCESS. ON 3/9/97 A GASTROENTEROLOGIST WAS CALLED AND THE CLIENT WAS SENT TO RADIOLOGY. PHYSICIAN WAS UNABLE TO PERFORM THE PROCEDURE. THE PT WAS ADMITTED TO THE HOSP. ON 3/10/97 THE TUBE WAS FOUND TO BE IN THE PERITONEAL SPACE, BALLOON INFLATED. THE PHYSICIAN WAS ABLE TO REPOSITION THE TUBE INTO GASTRIC LOCATION. ANTIBIOTICS WERE ADMINISTERED. THE PT DID NOT DVELOPED PERITONITIS. THE TUBE IS NOT TO BE CHANGED FOR 3-4 MONTHS TO ALLOW STOMA TRACT TO PROPERLY FORM. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO GASTROSTOMY TUBE 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT LABORATORIES, ROSS PRODUCTS DIV. 155 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R NONE REPORTED