BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT REPLACEMENT GASTRO TUBE

    MDR report key: 2128794 · Received June 13, 2011

    Report

    Report Number
    2110851-2011-00001
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 12, 2011
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    KNT
    PMA / PMN Number
    K885339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERFORMED AS INTENDED FOR UP TO SIX WEEKS. THE TYPE OF FAILURE DID NOT PLACE THE PATIENT AT RISK FOR SERIOUS INJURY AND THE PATIENT HAD SIMILAR ISSUES SEVERAL TIMES WITH A NON NESTLE PRODUCT. THE EVENT DOES NOT FIT THE DEFINITION OF A SERIOUS INJURY AND DOES NOT FIT THE DEFINITION OF PRODUCT MALFUNCTION. THE EVENT DOES FIT THE DEFINITION OF "MALFUNCTION" AS DEFINED IN 21 CFR PART 803. EXPIRATION DATE MAY HAVE BEEN EXCEEDED. THE SAMPLE WAS CLEARLY IDENTIFIED AS HAVING BEEN MANUFACTURED PRIOR TO JULY 1, 2008. THE PRODUCT HAS A THREE YEAR SHELF LIFE. THERE WERE NO LABELING OR PACKAGING PRESENT TO IDENTIFY A SPECIFIC LOT CODE OR EXPIRATION DATE.

    Description of Event or Problem · 1

    PATIENTS FATHER STATED THAT HIS DAUGHTER HAD A REPLACEMENT BALLOON GASTRO-TUBE PLACED SIX WEEKS AGO DOCTOR'S CLINIC. TODAY IT WAS DISCOVERED THAT THE BALLOON HAD BROKEN REQUIRING PATIENT TO GO TO THE EMERGENCY ROOM FOR TUBE REPLACEMENT. PATIENT LIVES IN A GROUP HOME WHERE THE LOOSE TUBE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT REPLACEMENT GASTRO TUBE TUBES, GASTROINTESTINAL AND ACCESSORIES KNT NESTLE HEALTHCARE NUTRITION, INC. 08741400 14 FR. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization