BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER WITH TEMPERATURE SENSOR

    MDR report key: 6916675 · Received October 5, 2017

    Report

    Report Number
    2320762-2017-00012
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    August 30, 2017
    Report Date
    December 14, 2017
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EYC
    PMA / PMN Number
    K041416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE CATHETER MANUFACTURER, DEGANIA SILICONE. IN ITS SCAR RESPONSE, DEGANIA STATED THE CONDITION REPORTED OCCURRED FOLLOWING IMPROPER USE OF THE CATHETER. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A WIRE WAS FOUND PROTRUDING FROM A FOLEY CATHETER NEAR THE EXTERNAL COLLECTION BAG. PRIOR TO THIS, THE DEVICE WAS NOT READING A TEMPERATURE. A SAMPLE WAS RECEIVED OCTOBER 9, 2017, AND FORWARDED TO THE CATHETER MANUFACTURER, DEGANIA SILICONE, FOR EVALUATION AND TESTING. IN ITS SCAR RESPONSE, DEGANIA INDICATED THE RETURNED SAMPLE HAD DEFORMED THERMOCOUPLE PROTRUDING FROM A TORN CATHETER WALL. PER THE MANUFACTURER, THIS CONDITION OCCURS IF THE SILICONE SHAFT IS STRONGLY PULLED AND QUICKLY RELEASED. SILICONE RETURNS ITS SHAPE MORE QUICKLY THAN THE SENSOR WIRE INSIDE, ALLOWING THE WIRE TO DEFORM AND CREATE BUMPS. THE INSTRUCTIONS FOR USE FOR THE DEVICE WARNS AGAINST PULLING ON THE CATHETER. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE WORK ORDER SHOWED THAT ONE CATHETER WAS REJECTED. HOWEVER, THIS WAS DUE TO THE CATHETER BEING DIRTY, NOT FOR A PROTRUDING WIRE. THE RAW MATERIAL AND FINISHED GOOD INVENTORY WAS CHECKED. NO NON-CONFORMING PRODUCT WAS FOUND. THE CATHETER PORTION OF THE DEVICE IS MANUFACTURED BY DEGANIA SILICONE. THEREFORE, A SCAR WAS ISSUED (B)(6) 2017, TO DEGANIA. A RESPONSE WAS RECEIVED (B)(6) 2017. PREVENTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. 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 WIRE WAS FOUND PROTRUDING FROM A FOLEY CATHETER NEAR THE EXTERNAL COLLECTION BAG. PRIOR TO THIS, THE DEVICE WAS NOT READING A TEMPERATURE. A SAMPLE WAS REPORTED TO BE AVAILABLE AND IS EXPECTED TO BE RETURNED. HOWEVER, AS OF THE DATE OF THIS REPORT, IT HAS NOT BEEN RECEIVED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE WORK ORDER SHOWED THAT ONE CATHETER WAS REJECTED. HOWEVER, THIS WAS DUE TO THE CATHETER BEING DIRTY, NOT FOR A PROTRUDING WIRE. THE RAW MATERIAL AND FINISHED GOOD INVENTORY WAS CHECKED. NO NON-CONFORMING PRODUCT WAS FOUND. THE CATHETER PORTION OF THE DEVICE IS MANUFACTURED BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED SEPTEMBER 12, 2017, TO (B)(4). A RESPONSE IS DUE OCTOBER 25, 2017. AS OF THE DATE OF THIS REPORT, THAT RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A WIRE WAS PROTRUDING FROM THE FOLEY CATHETER WITH TEMPERATURE SENSOR WHERE IT WOULD CONNECT TO THE EXTERNAL COLLECTION BAG. PRIOR TO THIS, THE TEMPERATURE WAS NO LONGER READING WHEN CONNECTED TO THE MONITOR.

    Description of Event or Problem · 1

    A WIRE WAS PROTRUDING FROM THE FOLEY CATHETER WITH TEMPERATURE SENSOR WHERE IT WOULD CONNECT TO THE EXTERNAL COLLECTION BAG. PRIOR TO THIS, THE TEMPERATURE WAS NO LONGER READING WHEN CONNECTED TO THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698708 FOLEY CATHETER WITH TEMPERATURE SENSOR CATHETER, UPPER URINARY TRACT EYC DEROYAL INDUSTRIES, INC. 81-080408 43865531

    Patients

    Seq Age Sex Outcome Treatment
    1