BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J FOR PEG KIT 20FR

    MDR report key: 7320107 · Received March 7, 2018

    Report

    Report Number
    3010757606-2018-00151
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 16, 2018
    Report Date
    February 19, 2018
    Manufacturer
    ABBVIE MEDICAL DEVICE CENTRE
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 0AV063-001 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 IN THE EVENT WAS DISCARDED AND WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. INTESTINAL PERFORATION AND PERITONITIS ARE KNOWN COMPLICATIONS OF A PEG- J 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 (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. DURING THE PEJ PLACEMENT, THE DUODENUM WAS PERFORATED. THE PLACEMENT OF THE PEJ WAS DISCONTINUED AND THE PEJ WAS REMOVED. THE PATIENT ONLY HAD THE PEG. ON (B)(6), THE PATIENT WAS DIAGNOSED WITH PERITONITIS. HE WAS DYING IN THE INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164521 ABBVIE J FOR PEG KIT 20FR KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE MEDICAL DEVICE CENTRE 32044357

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ABBVIE PEG TUBE, LOT # 32183256