BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE NJ

    MDR report key: 7992916 · Received October 22, 2018

    Report

    Report Number
    3010757606-2018-00623
    Event Type
    Injury
    Date Received
    October 22, 2018
    Report Date
    September 27, 2018
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062903-001 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 DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. 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 (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF NASO JEJUNAL (NJ) TUBE. DURING THE PLACEMENT, IT WAS REPORTED THAT THE TUBE "DID NOT GO FURTHER." A SUBSEQUENT ENDOSCOPY REVEALED SECRETIONS WITH A CLOT IN THE STOMACH WITH NO BLEEDING AND A DEEP ULCER IN FRONT OF THE PYLORUS. IT WAS REPORTED THAT THE PATIENT'S NASAL JEJUNAL TUBE WAS PULLED OUT BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830262 ABBVIE NJ TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT ABBVIE - MEDICAL DEVICE CENTER 1065812

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention