BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERAL FEEDING - RIGHT ANGLE FEEDING SET

    MDR report key: 1387024 · Received May 15, 2009

    Report

    Report Number
    3005099803-2009-02411
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 23, 2008
    Report Date
    April 20, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT OF DEVICE AND COMPLETION OF THE FAILURE ANALYSIS, 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 ENTERAL FEEDING - RIGHT ANGLE FEEDING SET WAS PLACED IN AN ENTERAL FEEDING DEVICE REPLACEMENT PROCEDURE IN 2008. THE PATIENT'S WEIGHT WAS NOT PROVIDED. PER THE COMPLAINANT, SINCE THIS DEVICE HAS BEEN IN PLACE, HAVE EXPERIENCED SEVERAL ISSUES WITH LEAKING DUE TO THE FEEDING SET. THE PATIENT IS FED FIVE TIMES A WEEK, OVERNIGHT. AT LEAST TWICE A WEEK DURING FEEDING, LEAKING IS OCCURRING AT THE MEDICINE PORT. THIS HAS CAUSED SO MUCH DISTRESS BOTH TO THE PATIENT AND HIS MOTHER. LEAKING IS SO EXTENSIVE THAT THE CHILD IS AWAKENED FROM SLEEP, THE CHILD'S NIGHT CLOTHES AND BED LINENS MUST BE CHANGED AND FEEDING IS OFTEN ABANDONED. THE PATIENT HAS LOST WEIGHT DUE TO THE RESULTING LACK OF NUTRIENTS RECEIVED. THE COMPLAINANT INDICATED THAT WITHOUT THE MEDICINE PORT ON THE FEEDING SET, THE LEAKAGE WOULD NOT OCCUR. THE MEDICINE PORT IS NOT USED. ON THE PORT THERE IS A TINY STOPPER WITH A BALL THAT LOCKS, BUT IT KEEPS COMING UNLOCKED AND THE BUTTON DOES NOT STAY IN. THE MOTHER HAS RESORTED TO TAPING THIS AREA UP WITH WATERPROOF TAPE, BUT THE LEAKING STILL OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERAL FEEDING - RIGHT ANGLE FEEDING SET KNT BOSTON SCIENTIFIC CORPORATION M00580181

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other