BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBVIE NJ

    MDR report key: 5193142 · Received October 30, 2015

    Report

    Report Number
    3010757606-2015-00034
    Event Type
    Death
    Date Received
    October 30, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 5, 2015
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MANUFACTURER AND LOT NUMBER OF THE NASO-JEJUNAL (NJ) TUBE INVOLVED IN THIS EVENT WAS NOT PROVIDED BY THE COMPLAINANT. THEREFORE, IT IS UNKNOWN IF THE TUBING INVOLVED WAS THE ABBVIE NJ. CONSERVATIVELY, ABBVIE HAS CHOSEN TO REPORT THIS EVENT DUE TO THE POTENTIAL THAT THE NJ TUBE INVOLVED COULD HAVE BEEN THE ABBVIE NJ. ABBVIE COMMERCIALLY HAS AVAILABLE ONE NJ TUBE AVAILABLE. THE CATALOG NUMBER IS LIST NUMBER 062903-001 WHICH IS THE US NJ TUBE AND THE UNIQUE IDENTIFIER FIELD NUMBER IS LIST 062903-002 WHICH IS THE INTERNATIONAL ABBVIE NJ TUBE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A BATCH RECORD REVIEW COULD NOT BE CONDUCTED. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING WAS DISCARDED. NO DEFECT, DEFICIENCY, OR MALFUNCTION OF THE NJ TUBE WAS DESCRIBED BY THE REPORTER. ABBVIE REVIEWED HISTORICAL COMPLAINT DATA AND NO COMPLAINT TRENDS WERE IDENTIFIED FOR THIS EVENT CONDITION. THE COMPLAINT DESCRIPTION DID NOT DESCRIBE ANY DEVICE MALFUNCTIONS, DEFICIENCIES OR DEFECTS. ASPIRATION PNEUMONIA IS A KNOWN COMPLICATION OF THE PRESENCE OF ANY INTESTINAL TUBE PLACED THROUGH THE OROPHARYNX, INCLUDING A NASOJEJUNAL (NJ) TUBE*. *((1) KWON RS ET AL. ENTERAL NUTRITION ACCESS DEVICES. GASTROINTEST ENDOSC 2010;72(2) :236-238 IF TUBING INVOLVED IN THIS EVENT WAS MANUFACTURED BY ABBVIE, THERE WERE NO ANOMALIES REPORTED WITH THE ABBVIE NJ TUBE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    AFTER THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT. THE DOCTOR'S REPORT INDICATED THAT THE PATIENT WAS REFERRED TO GASTROENTEROLOGY DEPARTMENT FOR AN ELECTIVE OUTPATIENT ENDOSCOPIC PLACEMENT OF A NASOJEJUNAL TUBE BEFORE THE PLANNED IMPLANTATION OF A PERCUTANEOUS ENDOSCOPIC GASTRO JEJUNOSTOMY (PEGJ) TUBE. PATIENT RETURNED AFTER THE PROCEDURE AND BECAME SOMNOLENT AND DEVELOPED HYPERTENSIVE CRISIS. THE PATIENT WAS REFERRED BACK TO THE GASTROENTEROLOGY DEPARTMENT. IT WAS REPORTED THAT AT THIS TIME, THE PATIENT BECAME AWAKE, REACTED TO VERBAL STIMULI AND WAS ORIENTED BUT EXPERIENCED HEADACHE. THE BLOOD PRESSURE WAS 190/100MMHG. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) AND BECAME SOMNOLENT AGAIN. CLINICAL EVALUATION AND X RAY REVEALED SEVERE ASPIRATION PNEUMONIA. IT WAS REPORTED THAT REPEATED "QUIET" ASPIRATION IN THE SCOPE OF THE UNDERLYING DISEASE WAS SUSPECTED. THE PATIENT WAS INITIALLY STABILIZED WITH ANTIBIOTICS, NON-INVASIVE VENTILATION AND VOLUME SUBSTITUTION. EXAMINATION OF TRACHEAL EXUDATE CONFIRMED ASPIRATION OF SALIVA AND DRUGS. BECAUSE OF THE PATIENT'S PROVISION, ONLY NON-INVASIVE VENTILATION WAS CARRIED OUT. FURTHER ASPIRATIONS LEAD TO A PROGRESSIVE WORSENING OF GAS EXCHANGE AND LOSS OF CONSCIOUSNESS AND THE PATIENT DIED ON (B)(6) 2015.

    Description of Event or Problem · 1

    A PHYSICIAN IN (B)(6) REPORTED ABOUT THE DEATH OF A PATIENT. THE PATIENT RECEIVED A NASAL TUBE ON (B)(6) 2015, BUT DURING THE PLACEMENT OF THE TUBE THE PATIENT ASPIRATED. THE TUBE WAS REMOVED. THE PATIENT SUFFERED FROM AN ASPIRATION PNEUMONIA THEREAFTER AND DIED ON (B)(6) 2015. THE PATIENT DID NOT GET DUODOPA TREATMENT. THE CLINIC WHERE THE ENDOSCOPY WAS PERFORMED WAS CALLED TO ASK FOR THE MANUFACTURER OF THE NASAL TUBE, BUT THEY WERE UNABLE TO PROVIDE ANY INFORMATION DUE TO DATA PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720796 ABBVIE NJ KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death