BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE ENTERAL FEEDING ADAPTERS

    MDR report key: 1937200 · Received December 23, 2010

    Report

    Report Number
    3005099803-2010-05215
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K014297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION SHOWED BLOCKAGE WAS NOTED IN THE Y-PORT AT POINT WHERE MEDICINE PORT AND FEEDING PORT JOIN. THE DEVICE WAS CUT LENGTHWISE AND A CLEAR SYRINGE CAP WAS FOUND TO HAVE BEEN FORCED INTO THE MEDICINE PORT. THE CAP WAS OBSTRUCTING FLUID FLOW THROUGH PORT THE MEDICINE PORT AND THE FEEDING PORT. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE WAS OCCLUDED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER/ USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 12073152.

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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 A Y-PORT ADAPTER WAS BEING USED FOR THE ADMINISTERING ENTERAL NUTRITION. THIS DEVICE WAS PLACED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010 THE FEEDING PORT ON THE Y-PORT ADAPTER, OF THE SECURI-T TUBE, WAS PARTIALLY CLOGGED. THE Y-PORT ADAPTER WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A Y-PORT ADAPTER WAS BEING USED FOR THE ADMINISTERING ENTERAL NUTRITION. THIS DEVICE WAS PLACED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010 THE FEEDING PORT ON THE Y-PORT ADAPTER, OF THE SECURI-T TUBE, WAS PARTIALLY CLOGGED. THE Y-PORT ADAPTER WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE ENTERAL FEEDING ADAPTERS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00580641 12073152

    Patients

    Seq Age Sex Outcome Treatment
    1