BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 4861634 · Received June 22, 2015

    Report

    Report Number
    1049092-2015-00359
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 8, 2015
    Manufacturer
    CONVATEC, INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL PT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS RECEIVED ON (B)(6) 2015. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE IRRIGATION PORT WAS USED TO INSERT THE MEDICATION. THE SYRINGE THAT COMES WITH THE DEVICE WAS USED. THE LINE WAS NOT CLAMPED AT ANY TIME PRIOR TO ATTEMPTING TO IRRIGATE. THE DEVICE WAS IN THE PT FOR 2 HRS. THERE WAS NO HARM TO THE PT. THE FMS WAS USED ON THE END USER ON A ROTOPRONE BED AND LOOSE STOOLS. THE MEDICATION THAT WAS BEING INSTILLED VIA THE IRRIGATION PORT WAS KAYEXALATE. THE NURSE WAS ATTEMPTING TO INSTILL MEDICATION AS WELL AS IRRIGATION. THE END USER WAS LAYING FLAT WHEN THE EVENT OCCURRED. THE DEVICE WAS REMOVED BECAUSE OF THE EVENT. THE SAME TYPE OF DEVICE WAS INSERTED WITH THE SAME MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICINE INSERTED INTO THE TUBE DID NOT GO THROUGH AND THE TUBE INFLATED. IT IS UNK AT THIS TIME WHICH PORT THE MEDICATION WAS INSERTED THROUGH OR IF THIS IS THE ENHANCED SIGNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403147 FLEXI-SEAL SIGNAL FMS KNT CONVATEC, INC 418000

    Patients

    Seq Age Sex Outcome Treatment
    1