BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 400 SERIES 10 FR

    MDR report key: 22411049 · Received July 7, 2025

    Report

    Report Number
    2320762-2025-00009
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 3, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EYC
    PMA / PMN Number
    K041416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "A 10FR FOLEY CATHETER WITH TEMPERATURE SENSOR WAS PLACED. WHEN THE CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] HOOKED UP THE CABLE TO THE SENSOR, THE TEMPERATURE WOULD NOT READ. " DEROYAL INDUSTRIES, INC. HAS REQUESTED RETURN OF THE DEVICE BUT IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER. THIS INVESTIGATION IS ONGOING AND NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "A 10FR FOLEY CATHETER WITH TEMPERATURE SENSOR WAS PLACED. WHEN THE CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] HOOKED UP THE CABLE TO THE SENSOR, THE TEMPERATURE WOULD NOT READ. " DEROYAL INDUSTRIES, INC. HAS REQUESTED RETURN OF THE DEVICE BUT IT WAS NOT AVAILABLE FOR RETURN. BASED ON THE LOT NUMBERS PROVIDED, DEROYAL IDENTIFIED THE DEROYAL LOTS OF THE TEMPERATURE WIRE SETS. FUNCTIONAL RESULTS FROM EACH OF THESE LOTS WERE REVIEWED AND CONFIRMED THAT ALL WERE WITHIN SPECIFICATION. THE RISK ASSESSMENT FOR FOLEYS WERE REVIEWED AND FOUND TO BE FULLY UP TO DATE AND IN NO NEED OF UPDATES. AN INVENTORY CHECK WAS UNABLE TO BE PERFORMED AS NO PRODUCT WAS AVAILABLE ON HAND. IT WAS INITIALLY STATED THAT A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WOULD BE ISSUED TO THE SUPPLIER, HOWEVER, UPON INVESTIGATION IT WAS DETERMINED THAT THE NATURE OF THIS ISSUE WOULD NOT BE ISSUED TO THE SUPPLIER, BUT RATHER STAY WITH DEROYAL. A COMPLAINT TO SALES RATIO WAS CONDUCTED FOR THE WIRE SETS OVER THE PAST TWO YEARS AND FOUND NO OTHER SIMILAR COMPLAINTS LEADING TO A COMPLAINT TO SALES RATIO OF 0%. ROOT CAUSE: BECAUSE THE SAMPLE WAS UNAVAILABLE FOR RETURN AND NO ISSUES COULD BE IDENTIFIED IN THE PRODUCTION RECORDS, THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "A 10FR FOLEY CATHETER WITH TEMPERATURE SENSOR WAS PLACED. WHEN THE CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] HOOKED UP THE CABLE TO THE SENSOR, THE TEMPERATURE WOULD NOT READ. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768077 FOLEY CATHETER, 400 SERIES 10 FR CATHETER, UPPER URINARY TRACT EYC DEROYAL INDUSTRIES, INC. 81-080410 61301801 

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown