BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 7865385 · Received September 11, 2018

    Report

    Report Number
    3010757606-2018-00526
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    September 1, 2018
    Report Date
    September 3, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4), CATALOG NUMBER 062903-002 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED, IT REMAINS IMPLANTED; THEREFORE A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. A BRONCHIAL INFECTION IS A KNOWN COMPLICATION OF A 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) 2018 A PATIENT IN BELGIUM UNDERWENT A PROCEDURE FOR THE PLACEMENT OF NASAL JEJUNAL (NJ) TUBE. ON (B)(6) 2018 IT WAS REPORTED THAT THE PATIENT HAS BRONCHITIS WITH A TEMPERATURE OF 38°C. ANTIBIOTIC TAZOCIN (INTRAVENOUS) WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704249 ABBVIE NJ TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 1065813

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R