BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURI-T

    MDR report key: 838735 · Received April 13, 2007

    Report

    Report Number
    6000048-2007-00136
    Event Type
    Injury
    Date Received
    April 13, 2007
    Date of Event
    March 20, 2007
    Report Date
    March 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    PMA / PMN Number
    K961345
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THE DEVICE HAD BEEN USED, THE INTERNAL BOLSTER HAD BEEN DETACHED FROM THE FEEDING TUBE, AND THERE WERE MULTIPLE NICKS AND CRACKS IN THE INTERNAL SURFACE AND EDGES OF THE BOLSTER. FLASH WAS FOUND AROUND THE DISTAL END OF THE SILICONE TUBE AND A DEFINED MOLDING LINE WAS FOUND ON THE DISTAL END OF THE TUBE. A FUNCTIONAL EVALUATION FOUND THAT THE CAPS OF THE Y-ADAPTOR FUNCTIONED PROPERLY AND THE EXTERNAL BOLSTER ON THE TUBE WAS ABLE TO BE MOVED WITHOUT ISSUE. THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. THREE POSSIBLE LOT NUMBERS HAVE BEEN IDENTIFIED FOR THE DEVICE INVOLVED: 9014701, 8954707 AND 8955510. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; SIMILAR COMPLAINTS WERE FOUND FOR THIS PART NUMBER, HOWEVER, NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THESE LOT NUMBERS. THE FEBRUARY 2007 15-MONTH TREND REPORT FOR THIS PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED: NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 23, 2007, THAT DURING THE REMOVAL OF A SECURI-T ENTERAL FEEDING DEVICE, HAD BEEN IN PLACE FOR FIVE MONTHS (PATIENT AGE AND GENDER UNKNOWN), THE "INNER BOLSTER WAS TORN AND DETACHED INSIDE THE PATIENT". "THE REMAINED BOLSTER WAS ABLE TO (BE) REMOVED WITH (THE) SCOPE" AND ANOTHER SAME DEVICE WAS PLACED. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURI-T KNT KNT BOSTON SCIENTIFIC M00568151 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention