BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPAT SPECIALTY PRODUCTS

    MDR report key: 2171921 · Received April 7, 2006

    Report

    Report Number
    2110851-2006-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2006
    Date of Event
    February 13, 2006
    Report Date
    March 17, 2006
    Manufacturer
    NOVARTIS NUTRITION CORP.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT DEVICE WAS RETURNED TO MFR WITH MEDWATCH FORM ON (B)(6) 2006. THE MEDWATCH FORM WAS REC'D IN AN ENVELOPE WITHOUT THE G-TUBE TO EVALUATE ON (B)(6) 2006. A LETTER WAS SENT BY NOVARTIS ON (B)(6) 2006 REQUESTING THE TUBE IN QUESTION BE SENT TO US. NOVARTIS WILL CONTINUE TO DILIGENTLY F/U WITH THE CUSTOMER TO OBTAIN THE TUBE FOR INVESTIGATION OF THE CONCERN. AS NOVARTIS DOES NOT HAVE THE SUSPECT DEVICE, NOVARTIS HAS NOT BEEN ABLE TO TEST IT. FURTHER, LOT CODE INFO WAS PROVIDED BY THE CUSTOMER ONLY A SAMPLE [ITEM] NUMBER SO AN EVAL COULD NOT BE COMPLETED ON A DEVICE FROM THE SAME PRODUCTION. FROM THE INFO PROVIDED BY THE CUSTOMER, IT APPEARS THAT THE BALLOON WAS OVERFILLED AND/OR THE EXTERNAL FIXATION DISK WAS TOO TIGHT ON THE SKIN. IF THIS OCCURS EXTRAVASATION MAY OCCUR AND LEAD TO BALLOON BREAKDOWN. THEREFORE, THIS EVENT IS PROBABLY THE RESULT OF USER ERROR.

    Description of Event or Problem · 1

    AS REPORTED IN THE CUSTOMER MEDWATCH FORM: "GASTROSTOMY TUBE FUNCTION CHECKED BY THE PHYSICIAN. SALINE INJECTED THROUGH THE GASTROSTOMY TUBE. EXTRAVASATION OF FLUID WAS NOTED AT THE SKIN. G-TUBE WAS REMOVED AND THE BALLOON WAS DEFLATED. BALLOON WAS NOTED TO LEAK WHEN FILLED. PT UNDERWENT AN EGD ON (B)(6) 2006 FOR THE DISLODGED G-TUBE. ATTEMPTS TO REPLACE G-TUBE WERE UNSUCCESSFUL. UNABLE TO PASS A GUIDEWIRE. GASTROSTOMY SITE WAS SEALED. THEREFORE, PLACEMENT OF A POST-PYLORIC DOBHOFF TUBE WAS DONE WITHOUT COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT SPECIALTY PRODUCTS GASTROSTOMY TUBE - 20 FR KNT NOVARTIS NUTRITION CORP. NOT APPLICABLE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention