BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE METER KIT WITH FOLEY CATHETER

    MDR report key: 6844283 · Received September 6, 2017

    Report

    Report Number
    2320762-2017-00010
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 3, 2017
    Report Date
    January 10, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    FCM
    PMA / PMN Number
    K951178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(6), THE DEVICE MANUFACTURER. IN ITS SCAR RESPONSE, (B)(6) STATED RETAINED SAMPLES WERE TESTED AND FOUND TO FUNCTION PROPERLY. FLUID SUCCESSFULLY FLOWED INTO THE URINE METER AT INITIAL USE DURING TESTING. THESE RESULTS INDICATE NO ISSUES FOR FLUIDS PASSING THROUGH THE TUBE TO THE BAG/URINE METER. THEREFORE, BASED ON THESE RESULTS AND THE PHOTOS OF THE DEFECTIVE SAMPLE, THERE MAY HAVE BEEN SUBSTANCES IN THE PATIENT'S URINE THAT CAUSED THE NON-RETURN VALVE TO STICK TOGETHER, PREVENTING URINE PASS THROUGH. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(6) STATED A FIVE-YEAR REVIEW OF COMPLAINTS SHOWED NO SIMILAR REPORTS. THE MANUFACTURER BELIEVES THIS IS AN ISOLATED INCIDENT AND WILL CONTINUE TO TRACK THE QUALITY STATUS OF THIS PRODUCT. THE REPORTED ISSUE WAS COMMUNICATED TO THE RIP CHAMBER WORKSHOP TO WARN THEM OF THIS PROBLEM AND STRICTLY MONITOR PRODUCT QUALITY. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A URINE METER KIT (FINISHED GOOD 81-080518, LOT 44276084) CONTAINED A FOLEY CATHETER THAT DID NOT DRAIN URINE INTO THE UROMETER OR COLLECTION BAG. A SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PHOTOS OF THE INCIDENT WERE PROVIDED. THE RAW MATERIAL INVENTORY OF THE FOLEY CATHETER AND URINE METER WAS VISUALLY INSPECTED. NO DEFECTS IN THE PHYSICAL MAKEUP OF THE PARTS WERE SEEN. THREE EACH OF THE CATHETER AND URINE METER WERE SENT TO DEROYAL ENGINEERING FOR FUNCTIONAL TESTING, AND ALL PARTS FUNCTIONED CORRECTLY. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. ANALYSIS OF THE PHOTOS PROVIDED BY THE END USER SHOW THAT THE CATHETER IS ALLOWING FLUID TO FLOW INTO THE URINE METER. THEREFORE, IT HAS BEEN DETERMINED THE FAILURE MAY HAVE OCCURRED IN THE URINE METER, WHICH IS SUPPLIED TO DEROYAL BY (B)(6). A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED AUGUST 18, 2017, TO (B)(6), AND A RESPONSE IS DUE OCTOBER 2, 2017. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. PREVENTIVE ACTION: (B)(6) INDICATED IN ITS SCAR RESPONSE THAT THE INSPECTION LEVEL WAS STRENGTHENED FOR THE NEXT THREE LOTS PRODUCED WITH HIGHER ATTENTION PAYED TO PRODUCT FUNCTION TEST. ALL INSPECTORS, INCLUDING INCOMING, IN-PROCESS, AND FINAL RELEASE, WERE TRAINED AND REQUIRED TO REINFORCE THE INSPECTION IN EVERY LINK. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT A URINE METER KIT (FINISHED GOOD 81-080518, LOT 44276084) CONTAINED A FOLEY CATHETER THAT DID NOT DRAIN URINE INTO THE UROMETER OR COLLECTION BAG. A SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PHOTOS OF THE INCIDENT WERE PROVIDED. THE RAW MATERIAL INVENTORY OF THE FOLEY CATHETER AND URINE METER WAS VISUALLY INSPECTED. NO DEFECTS IN THE PHYSICAL MAKEUP OF THE PARTS WERE SEEN. THREE EACH OF THE CATHETER AND URINE METER WERE SENT TO DEROYAL ENGINEERING FOR FUNCTIONAL TESTING, AND ALL PARTS FUNCTIONED CORRECTLY. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. ANALYSIS OF THE PHOTOS PROVIDED BY THE END USER SHOW THAT THE CATHETER IS ALLOWING FLUID TO FLOW INTO THE URINE METER. THEREFORE, IT HAS BEEN DETERMINED THE FAILURE MAY HAVE OCCURRED IN THE URINE METER, WHICH IS SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED AUGUST 18, 2017, TO (B)(4), AND A RESPONSE IS DUE OCTOBER 2, 2017. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE END USER REPORTED THE FOLEY DOESN'T DRAIN URINE INTO THE UROMETER OR COLLECTION BAG. THE PRODUCT IS BEING USED ON KIDNEY TRANSPLANT PATIENTS. THE HOSPITAL STAFF HAS BEEN UNABLE TO USE THE PRODUCT AS INTENDED, AND IT IS CAUSING A LOT OF FRUSTRATION.

    Description of Event or Problem · 1

    THE END USER REPORTED THE FOLEY DOESN'T DRAIN URINE INTO THE UROMETER OR COLLECTION BAG. THE PRODUCT IS BEING USED ON KIDNEY TRANSPLANT PATIENTS. THE HOSPITAL STAFF HAS BEEN UNABLE TO USE THE PRODUCT AS INTENDED, AND IT IS CAUSING A LOT OF FRUSTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625280 URINE METER KIT WITH FOLEY CATHETER TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT) FCM DEROYAL INDUSTRIES, INC. 81-080518 44276084

    Patients

    Seq Age Sex Outcome Treatment
    1