BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 5404773 · Received February 2, 2016

    Report

    Report Number
    3010757606-2016-00016
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 6, 2016
    Report Date
    January 6, 2016
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIALLY IT WAS THOUGHT THAT THE DEVICE INVOLVED IN THE EVENT WAS A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY AND JEJUNOSTOMY (PEGJ) TUBE MANUFACTURED BY ABBVIE. AFTER THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, IT WAS NOTED THAT THE EVENT OF INFECTION OCCURRED WITH THE USE OF A BOSTON SCIENTIFIC MANUFACTURED DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATALOG NUMBER PROVIDED IS THE US LIST NUMBER THAT IS THE SAME AS THE INTERNATIONAL LIST NUMBER IN THE UNIQUE IDENTIFIER FIELD. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING REMAINS IMPLANTED. BATCH RECORD REVIEW WAS PERFORMED FOR THE LOT# PROVIDED. ALL PARAMETERS WERE WITHIN SPECIFICATION INCLUDING STERILIZATION CRITERIA. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. NOTHING WAS IDENTIFIED IN THE BATCH RECORD REVIEW WHICH COULD LEAD TO THE CONDITION IDENTIFIED. STOMATITIS IS A KNOWN COMPLICATION OF A PEG TUBE PLACEMENT. THE ABBVIE PEG TUBE IS INTENDED TO PROVIDE LONG-TERM ENTERAL ACCESS FOR ADMINISTRATION OF MEDICATION TO THE SMALL INTESTINE WHEN USED IN CONJUNCTION WITH THE ABBVIE J, INTESTINAL TUBE. AS NEEDED, ENTERAL NUTRITION MAY BE ADMINISTERED DIRECTLY TO THE STOMACH IN PARALLEL WITH MEDICATION DELIVERY TO THE INTESTINE. THE ABBVIE PEG IS INDICATED FOR THE ADMINISTRATION OF THE MEDICATION DUOPA (CARBIDOPA AND LEVODOPA ENTERAL SUSPENSION). REVIEW OF THE ABBVIE PEG AND J DESIGN AND USE FMEAS IDENTIFIED SEVERAL STEPS IN THE PLACEMENT PROCEDURE THAT COULD POTENTIALLY CONTRIBUTE TO BIOLOGICAL CONTAMINATION OF THE STOMA SITE. THOSE STEPS INCLUDE DISINFECTING THE PUNCTURE SITE USING ASEPTIC TECHNIQUE, INSTALLATION OF THE EXTERNAL FIXATION PLATE, AND CLEANING AND DRYING THE PUNCTURE SITE. ADDITIONALLY, ONGOING POST-PROCEDURE CARE IS IMPORTANT TO MINIMIZE STOMATITIS. THE ABBVIE PEG AND J RISK MANAGEMENT REPORT DOCUMENTS STOMA INFECTIONS AS A RISK, INDICATING THAT THE RISKS HAVE BEEN REDUCED AS LOW AS POSSIBLE THROUGH PRODUCT DESIGN AND PLACEMENT PROCEDURE, AND THE BENEFITS OF THE DUOPA SYSTEM OUTWEIGH THE RISKS OF STOMA INFECTION. THE REPORT ALSO CITES A LITERATURE REFERENCE INDICATING TYPICAL PERISTOMAL SITE INFECTION RATES. ¿PERISTOMAL SITE INFECTION IS THE MOST COMMONLY REPORTED COMPLICATION OF PEG AND IS SEEN IN AS MANY AS 30% OF CASES. MORE THAN 70% OF THESE INFECTIONS ARE MINOR, WITH FEWER THAN 1.6% REQUIRING AGGRESSIVE MEDICAL OR SURGICAL TREATMENT.¿(1). ITKIN M, DELEGGE MH, FANG JC, ET AL. MULTIDISCIPLINARY PRACTICAL GUIDELINES FOR GASTROINTESTINAL ACCESS FOR ENTERAL NUTRITION AND DECOMPRESSION FROM THE SOCIETY OF INTERVENTIONAL RADIOLOGY AND AMERICAN GASTROENTEROLOGICAL ASSOCIATION (AGA) INSTITUTE, WITH ENDORSEMENT BY CANADIAN INTERVENTIONAL RADIOLOGICAL ASSOCIATION (CIRA) AND CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (CIRSE). GASTROENTEROLOGY. 2011;141(2):742-65. ABBVIE REVIEWED HISTORICAL COMPLAINT DATA AND NO TRENDS WERE IDENTIFIED FOR STOMA RELATED COMPLICATIONS. THERE ARE NO ANOMALIES WITH THE ABBVIE PEG TUBE REPORTED THAT WOULD CONTRIBUTE TO THE EVENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION AT THE PEGJ AREA WITH BOSTON TUBE AND ANTIBIOTIC WAS STARTED. ON (B)(6) 2016, THE NURSE REPORTED THE INFECTION WAS RECOVERED BUT THE DISCHARGE CONTINUED. ON (B)(6) 2016, THE PATIENT WENT TO HOSPITAL AND THE PEG/J TUBE WAS CHANGED WITH AN ABBVIE PEG/J TUBE. ORAL ANTIBIOTIC WAS CONTINUED TILL (B)(6) 2016 AND THE INFECTION AND DISCHARGE CONTINUED TILL (B)(6) 2016.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) EXPERIENCE AN INFECTION AROUND THE STOMA SITE. THE PATIENT WENT TO THE HOSPITAL TO HAVE THE PEG-J TUBES REPLACED. GASTROENTEROLOGIST SUSPECTED A BURIED BUMPER, HOWEVER, THE GENERAL SURGEON STATED THAT THERE WAS NOT BURIED BUMPER. THE PATIENT WAS TREATED WITH AUGMENTIN AND CIPRO TO TREAT INFECTION AT THE PEG-J ENTRANCE AREA AND THE TREATMENT WAS DISCONTINUED ON (B)(6) 2016. INFECTION AND DISCHARGE ON ENTRANCE OF PEG-J AREA ARE STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62326 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32294374

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PK MERZ