BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ JEJUNAL FEEDING TUBE

    MDR report key: 3030495 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-01989
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K091340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF CAP LOOSE. (B)(4) FOR THE REPORTED EVENT OF CAP LEAKING. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE THREE-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE WAS PLACED. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE CAP OF THE FEEDING PORT WOULD NOT CLOSE PROPERLY, LEADING TO LEAKAGE OF STOMACH CONTENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135197 ENDOVIVE¿ JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566330

    Patients

    Seq Age Sex Outcome Treatment
    1