BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVEEN STANDARD 1500 ML

    MDR report key: 3071249 · Received April 22, 2013

    Report

    Report Number
    9610694-2013-00004
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT EVALUATION WAS AVAILABLE AT THE TIME OF THIS REPORT. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECIEVED, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT EVALUATION WAS AVAILABLE AT THE TIME OF THIS REPORT. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED. 6 BAGS WERE RETURNED. THE FOLLOWING TESTS WERE PERFORMED; VISUAL INSPECTION, PRESSURE/TIME REQUIRED TO INITIATE FLOW AND FILLING RATE. ALL RECEIVED BAGS PERFORMED ACCORDING TO SPECIFICATIONS. THE MANUFACTURING RECORDS INDICATED THAT PRODUCTION OPERATED NORMALLY AND ALL INSPECTIONS WERE COMPLETED AND PASSED. ACCORDING TO THE DESCRIPTION THE URINE BLOCK MAY HAVE BEEN POTENTIALLY CAUSED BY THE INLET TUBE JAM DUE TO THE ANTI REFLUX VALVE BEING SQUEEZED DUE TO INAPPROPRIATE FOLDING. THE OPERATORS HAVE BEEN INSTRUCTED TO CHECK IF THE ANTI REFLUX VALVE IS INTACT BEFORE WELDING. THE OPERATORS HAVE ALSO BEEN INSTRUCTED TO IMPLEMENT 100% AIR TESTING DURING PRODUCTION.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A URINE BAG WITH BLOCKED URINEFLOW. IT WAS STATED THAT THE URINE WAS FLOWING BACKWARDS.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2013 ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A URINE BAG WITH BLOCKED URINEFLOW. IT WAS STATED THAT THE URINE WAS FLOWING BACKWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171577 CONVEEN STANDARD 1500 ML URINE BAGE FAQ COLOPLAST A/S 0506201060 3552427

    Patients

    Seq Age Sex Outcome Treatment
    1