BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYS KIT

    MDR report key: 4197048 · Received October 21, 2014

    Report

    Report Number
    1049092-2014-00519
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    CONTACT INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO UNTOWARD EVENT WITH THE PT WHATSOEVER PER THE INFO RECEIVED. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. 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. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED WHILE ATTEMPTING TO IRRIGATE THE DEVICE, THE FLOW WAS OBSTRUCTED AND THE IRRIGATING SOLUTION BEGAN TO BALLOON AT THE IRRIGATION PORT AND DID NOT MAKE ITS WAY DOWN THE TUBING AND INTO THE PT. THE HLTH CARE PHYSICIAN ENSURED THERE WERE NO KINKS OR OBSTRUCTIONS TO THE TUBING. THE CLINICIAN REMOVED AND REPLACED THE PRODUCT WITH NO FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670080 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYS KIT GASTROINTESTINAL TUBE AND ACCESSORIES, 78 KNT KNT CONTACT INC 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention