BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 6940087 · Received October 11, 2017

    Report

    Report Number
    3010757606-2017-00470
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 21, 2017
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062903-002 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN MODEL #/LOT # WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. PNEUMONIA IS A KNOWN COMPLICATION OF AN NJ TUBE PLACEMENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF NASAL JEJUNAL (NJ) TUBE. ON (B)(6) 2017, THE PATIENT HAD INCREASED CRP AND A FEVER AND PNEUMONIA WAS DIAGNOSED. THE SAME DAY, THE PATIENT BEGAN TREATMENT WITH ANTIBIOTIC UNASYN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722114 ABBVIE NJ KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE 1046165

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention