BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE J

    MDR report key: 5611241 · Received April 27, 2016

    Report

    Report Number
    3010757606-2016-00089
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    September 1, 2015
    Report Date
    September 28, 2015
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH RECORD REVIEW WAS PERFORMED FOR THE LOT NUMBER PROVIDED, AND NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. NO DEFECT, DEFICIENCY, OR MALFUNCTION OF THE ABBVIE J TUBE WAS DESCRIBED. THE BATCH RECORD REVIEW DID NOT IDENTIFY ANY PROBABLE OR ROOT CAUSES THAT WOULD CONTRIBUTE TO THE PATIENT¿S CONDITION. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING WAS NOT AVAILABLE. NO CORRECTIVE OR PREVENTIVE ACTIONS HAVE BEEN IDENTIFIED AT THIS TIME. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062918-002 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED, WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE A RETURN SAMPLE EVALUATION WILL NOT BE PERFORMED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE BATCH RECORD REVIEW OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED. THE TWO LOT NUMBERS THAT ARE REPORTEDLY INVOLVED IN THE EVENT ARE 32294384 AND 32224185. SINCE IT IS UNSURE WHICH LOT NUMBER WAS INVOLVED IN THE EVENT, THIS REPORT IS FOR LOT NUMBER 32224185 ABBVIE RECORD 823917. LOT NUMBER 32294384 IS BEING REPORTED ON ABBVIE RECORD NUMBER (B)(4).

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE A PATIENT IN (B)(6) UNDERWENT SURGERY TO INSERT A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) AND JEJUNOSTOMY (PEJ) TUBE. THE PROCEDURE WAS A RADIOLOGICAL INSERTION. PATIENT EXPERIENCED A PERFORATED BOWEL FROM THE SURGERY. THE PATIENT DEVELOPED PERITONITIS AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPERATION AND AN OPERATION TO WASH OUT STOMACH AND SEW UP HOLE WAS REPORTED. THE DUODOPA WAS NOT REINTRODUCED. TWO PEJ TUBES WERE USED DURING THE PROCEDURE, HOWEVER IT IS UNKNOWN WHICH TUBE BATCH NUMBER WAS BEING IMPLANTED WHEN THE PERFORATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265839 ABBVIE J KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32224185

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention