BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FECAL MANAGEMENT SYSTEM

    MDR report key: 6104368 · Received November 15, 2016

    Report

    Report Number
    1049092-2016-00468
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 20, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K302734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION CONFIRMED RECEIPT OF ONE UNUSED CONVATEC PRODUCT THAT DID SHOW IRRITATION PORT DETACHED FROM CATHETER. THE DEVICE WAS DISPOSED OF ON 11/02/2016. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A PRODUCT MALFUNCTION. BASED ON INFORMATION PROVIDED, NO PATIENT HARM OCCURRED. RETURN SAMPLES WERE RECEIVED; HOWEVER THIS IS A KNOWN COMPLAINT ISSUE WHICH HAS BEEN INVESTIGATED. THE RETURNED SAMPLE WAS EVALUATED TO DETERMINE THAT IT WAS INDEED CONVATEC PRODUCT. NO ADDITIONAL EVALUATION OF THE RETURN SAMPLE IS REQUIRED. A PREVIOUS ROOT CAUSE INVESTIGATION AND CAUSALITY ASSESSMENT FOR THIS KNOWN COMPLAINT ISSUE HAS BEEN CONDUCTED. RETENTION SAMPLES FOR FLEXI-SEAL STANDARD FMS (ICC # (B)(4)) WERE EVALUATED IN A PREVIOUS ROOT CAUSE INVESTIGATION. THE MANUFACTURING PROCESS, QUALITY INSPECTION, PACKAGING PROCESS, AND QUALITY CONTROL RECORDS WERE REVIEWED. SIMULATION TESTING INCLUDING ADHESION/TENSILE STRENGTH TESTING IN THE REVERSE DIRECTION WAS PERFORMED. THE APPEARANCE OF THE BALLOON, CATHETER BODY AND VALVE FUNCTION WERE NORMAL. NO BROKEN TUBE AND SEPARATIONS AT JOINT WERE FOUND. THE INVESTIGATION OF THE RETENTION SAMPLES FOUND THREE PROBABLE ROOT CAUSES FOR THE REPORTED MALFUNCTION AND THEY ARE AS FOLLOWS: LUMEN/SILICONE TUBE MATERIAL STRENGTH/THICKNESS EXCESSIVE FORCE-PULL SYRINGE BEFORE COMPLETELY TWISTING LUER CONNECTION TO REMOVE THE SYRINGE AFTER USE 3. EXCESSIVE FORCE-ROTATIONAL FORCE WHEN ATTACHING/REMOVING SYRINGE DURING USE; THE INVESTIGATION DID NOT IDENTIFY ANY DEFECTS SPECIFIC TO THE LUMEN, ADHESIVE, PROCESSING, SHELF LIFE OR JHT. NO NON-CONFORMANCES FROM THE MANUFACTURING PROCESS WERE IDENTIFIED. THE RISK DOCUMENTATION ALIGNS WITH THE POST MARKET FIELD DATA FOR OCCURRENCE OF THE BROKEN LUMEN, THEREFORE, THE DESIGN IS PERFORMING AS INTENDED. ALL THE TESTING AVAILABLE SUPPORTS THAT THE PRODUCT CAN WITHSTAND A REASONABLE AMOUNT OF FORCE 1.25~2.58 KG FORCE, I.E., 12.3 N - 25.3 N. THE MALFUNCTION MAY OCCUR WHEN THE FORCE IS COMBINED WITH INCOMPLETE DETACHMENT OF THE SYRINGE FROM THE LUER LOCK. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 15, 2016. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT FROM A NURSE REPORTING A DEVICE IRRIGATION PORT FAULT. REPORTER STATED THE "IRRIGATION PORT WAS DETACHED FROM MAIN CATHETER. DEFECTIVE PART WAS DISCOVERED BEFORE USING THE DEVICE." NO FURTHER INFORMATION WAS PROVIDED. A PHOTOGRAPH WAS PROVIDED BY THE COMPLAINANT DEPICTING THE REPORTED COMPLAINT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755567 FLEXI-SEAL FECAL MANAGEMENT SYSTEM TUBES, GASTROINTESTINAL AND ACCESSORIES KNT CONVATEC INC. 411100 12-FM-01

    Patients

    Seq Age Sex Outcome Treatment
    1