BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS

    MDR report key: 3865312 · Received February 7, 2014

    Report

    Report Number
    2243969-2014-00034
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT IS REPORTED THAT THE COMPLAINANT BELIEVES THAT THERE WAS NO HARM TO THE PT. IT IS ALSO REPORTED THAT COMPLAINANT HAS THE DEVICE AND IT WILL BE RETURNED TO CONVATEC FOR EXAMINATION. CONVATEC HAS ALSO ATTEMPTED TO CONTACT (B)(6), OPERATING ROOM EDUCATOR, PHONE (B)(6) TO REQUEST FURTHER INFO. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINT ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE FLEXISEAL INFLATION PORT SPEWED LIQUID DURING AN OPERATING ROOM PROCEDURE AND THE DEVICE WAS REMOVED FROM THE PT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80694 FLEXI-SEAL CONTROL FMS GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1