BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 6281634 · Received January 26, 2017

    Report

    Report Number
    3010757606-2017-00040
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    January 18, 2017
    Report Date
    January 19, 2017
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    142792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 LISTED IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT IS EXPECTED TO BE RETURNED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, IT WAS NOTED THAT ALTHOUGH THE EVENT OCCURRED DURING THE PROCEDURE TO PLACE ABBVIE NASO JEJUNAL (NJ) TUBE, THE NJ TUBE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT; THEREFORE, THIS EVENT IS NOT REPORTABLE.

    Description of Event or Problem · 1

    REPORT ON (B)(6) 2017 INDICATED THAT, DURING THE ATTEMPT TO PLACE THE NASO JEJUNAL TUBE, THE SMALL INTESTINE WAS INJURED WITH THE GRASPING FORCEPS AND WAS BLEEDING. THE PLACEMENT WAS TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61623 ABBVIE NJ KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE 1060233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT PRODUCTS NOT REPORTED