BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3810670 · Received March 24, 2014

    Report

    Report Number
    2243969-2014-00126
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL 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 EVALUATION IS NOT EXPECTED. (B)(4). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    NURSE REPORTED OF DIFFICULTIES TO INFLATE BALLOON. HE ATTEMPTED TO USE ANOTHER UNIT AND WAS SUCCESSFUL WITH THE SECOND UNIT. IT IS ALSO REPORTED THAT LEAKAGE WAS NOTICED AT THE AUTO VALVE WITH FILL INDICATOR. NO UNTOWARD EFFECT TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172554 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1