BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS KIT

    MDR report key: 6048163 · Received October 21, 2016

    Report

    Report Number
    1049092-2016-00445
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    October 7, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A PRODUCT MALFUNCTION. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A PREVIOUS ROOT CAUSE INVESTIGATION AND CAUSALITY ASSESSMENT FOR THIS KNOWN COMPLAINT ISSUE HAS BEEN CONDUCTED. RETENTION SAMPLES FOR FLEXI-SEAL STANDARD FMS ((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. EXCESSIVE FORCE-ROTATIONAL FORCE WHEN ATTACHING/REMOVING SYRINGE DURING USES. THE MOST PROBABLE ROOT CAUSE WAS THE EXTERNAL FORCE WHICH EXCEEDS THE LUMEN JOINT STRENGTH OF AROUND 1.25~2.58 KG FORCE. 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. THIS EVALUATION WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING AN INFLATION PORT ISSUE WITH THE DEVICE. REPORTER STATED "ONCE OPENED THE DEVICE THE CUSTOMER REALIZED THAT WAS MISSING THE IRRIGATION PORT." THE DEVICE WAS NO USED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698566 FLEXI-SEAL FMS KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC INC. 411100 16FM0001

    Patients

    Seq Age Sex Outcome Treatment
    1