BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT REPLACEMENT BALLOON GASTROSTOMY TUBE

    MDR report key: 1690003 · Received May 7, 2010

    Report

    Report Number
    2110851-2010-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 30, 2010
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC
    Product Code
    KNT
    PMA / PMN Number
    K885339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED AND CONFIRMED TO HAVE BURST BALLOON. NO OTHER TESTING WAS PERFORMED ON AFFECTED DEVICE. INVESTIGATION OF SIMILAR PRODUCT FROM SAME LOT IS IN-PROCESS. INVESTIGATION ON-GOING. PRELIMINARY TEST OF SAME LOT INDICATES DEVICE WORKS AS INTENDED. PT'S WIFE STATES SHE INFLATED BALLOON WITH 20CC WATER. DEVICE LABELING INSTRUCTIONS FOR USE INSTRUCTS CAREGIVER TO FILL WITH 15CC.

    Description of Event or Problem · 1

    PT'S WIFE STATES, SHE HAD PUT IN HER HUSBAND'S G-TUBE AND 5 DAYS LATER, HEARD A POP AND FOUND THE TUBE LAYING ON HIS CHEST. PT'S SPOUSE STATES, AT THE TIME THIS HAPPENED, THEY WERE NOT FEEDING PT. TUBE WAS PLACED BY WIFE AS THEY CHANGE IT EVERY 3 MONTHS. USED 20 CC'S OF TAP WATER TO FILL BALLOON. SHE STATES, NO FOOD CONTAINER TO SEND BACK AS THEY WERE NOT FEEDING AT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT REPLACEMENT BALLOON GASTROSTOMY TUBE REPLACEMENT GASTROSTOMY TUBE KIT KNT NESTLE HEALTHCARE NUTRITION, INC 22 FR 3378N

    Patients

    Seq Age Sex Outcome Treatment
    1