BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 2772166 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04658
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT UPN AND DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): J-TUBE KINKED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS USED DURING A PROCEDURE (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE J-TUBE BECAME KINKED, SETTING OFF THE HIGH PRESSURE ALARM. A REPLACEMENT OF THE DEVICE IS REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS USED DURING A PROCEDURE (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, APPROXIMATELY 8 MONTHS AFTER THE DEVICE WAS PLACED, THE J-TUBE BECAME KINKED, SETTING OFF THE HIGH PRESSURE ALARM. A REPLACEMENT OF THE DEVICE IS REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS USED DURING A PROCEDURE (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, APPROXIMATELY 8 MONTHS AFTER THE DEVICE WAS PLACED, THE J-TUBE BECAME KINKED, SETTING OFF THE HIGH PRESSURE ALARM. A REPLACEMENT OF THE DEVICE IS REQUIRED. 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
    1 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 DUODOPA