BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER, 400 SERIES 16 FR (+/-0.1C)

    MDR report key: 23817646 · Received December 16, 2025

    Report

    Report Number
    2320762-2025-00021
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 9, 2025
    Report Date
    January 16, 2026
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EYC
    UDI-DI
    00749756596664
    PMA / PMN Number
    K200757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE NEED TO REPLACE THREE BLADDER CATHETERS WITH THERMISTOR CH16 REF 81-080416EU IS REPORTED DUE TO REPEATED DEFLATION OF THE BALLOON AND CONSEQUENT DISPLACEMENT OF THE CATHETER. IN ALL CASES, THE CATHETER WAS FOUND OUT OF PLACE WITH THE BALLOON DEFLATED. IT SHOULD BE NOTED THAT THE PROBLEM OCCURRED WITH ONLY ONE PATIENT AND THAT HIM WAS LATER DISCOVERED WITH A URETHRAL STONE, THUS RAISING THE QUESTION OF A CORRELATION WITH THE EVENT THAT OCCURRED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT THE DEVICE WAS UNABLE TO BE RETURNED AS IT HAD BEEN DISCARDED. DEROYAL REVIEWED THE WORK ORDER AND NO DISCREPANCIES WERE FOUND. INVENTORY OF 2831 RAW MATERIALS WAS INSPECTED AND NO ISSUES WERE FOUND BY VISUAL INSPECTION. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, SPECTRUM PLASTICS (XERIDIEM). BECAUSE NO SAMPLE WAS RETURNED, SPECTRUM COULD NOT INSPECT THE SAMPLE FOR SPECIFIC ISSUES. THE DEVICE HISTORY RECORD FOR THE LOT OF THE RETURNED PRODUCT WAS INSPECTED AND NO ISSUES WERE FOUND AS ALL PRODUCTS WERE FOUND TO BE WITHIN SPECIFICATIONS. EACH BALLOON UNDERGOES A 100% INFLATION TEST AS PART OF THE QUALITY ASSURANCE PROCESS. THE BALLOON IS INFLATED AND MAINTAINED IN THE INFLATED STATE FOR APPROXIMATELY 10 MINUTES. DURING THIS PERIOD, ANY DEFECTS SUCH AS LEAKS, STRUCTURAL WEAKNESS, OR MATERIAL INCONSISTENCIES ARE IDENTIFIED. THERE ARE POTENTIAL EXTERNAL FACTORS THAT COULD CONTRIBUTE TO A BALLOON TEAR SUCH AS MECHANICAL STRESS FROM OVERINFLATION DUE TO INAPPROPRIATE SYRINGE USE OR OTHER FACTORS SUCH AS TEMPERATURE EXTREMES AND POOR PLACEMENT TECHNIQUES. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT RETURNED AND NO ISSUES COULD BE FOUND WITHIN THE MANUFACTURING RECORDS, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE COULD NOT BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE NEED TO REPLACE THREE BLADDER CATHETERS WITH THERMISTOR CH16 REF 81-080416EU IS REPORTED DUE TO REPEATED DEFLATION OF THE BALLOON AND CONSEQUENT DISPLACEMENT OF THE CATHETER. IN ALL CASES, THE CATHETER WAS FOUND OUT OF PLACE WITH THE BALLOON DEFLATED. IT SHOULD BE NOTED THAT THE PROBLEM OCCURRED WITH ONLY ONE PATIENT AND THAT HIM WAS LATER DISCOVERED WITH A URETHRAL STONE, THUS RAISING THE QUESTION OF A CORRELATION WITH THE EVENT THAT OCCURRED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT THE DEVICE WAS UNABLE TO BE RETURNED AS IT HAD BEEN DISCARDED. DEROYAL REVIEWED THE WORK ORDER AND NO DISCREPANCIES WERE FOUND. INVENTORY OF 2831 RAW MATERIALS WAS INSPECTED AND NO ISSUES WERE FOUND BY VISUAL INSPECTION. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE CONTRACT MANUFACTURER, SPECTRUM PLASTICS (XERIDIEM). BECAUSE NO SAMPLE WAS RETURNED, SPECTRUM COULD NOT INSPECT THE SAMPLE FOR SPECIFIC ISSUES. THE DEVICE HISTORY RECORD FOR THE LOT OF THE RETURNED PRODUCT WAS INSPECTED AND NO ISSUES WERE FOUND AS ALL PRODUCTS WERE FOUND TO BE WITHIN SPECIFICATIONS. EACH BALLOON UNDERGOES A 100% INFLATION TEST AS PART OF THE QUALITY ASSURANCE PROCESS. THE BALLOON IS INFLATED AND MAINTAINED IN THE INFLATED STATE FOR APPROXIMATELY 10 MINUTES. DURING THIS PERIOD, ANY DEFECTS SUCH AS LEAKS, STRUCTURAL WEAKNESS, OR MATERIAL INCONSISTENCIES ARE IDENTIFIED. THERE ARE POTENTIAL EXTERNAL FACTORS THAT COULD CONTRIBUTE TO A BALLOON TEAR SUCH AS MECHANICAL STRESS FROM OVERINFLATION DUE TO INAPPROPRIATE SYRINGE USE OR OTHER FACTORS SUCH AS TEMPERATURE EXTREMES AND POOR PLACEMENT TECHNIQUES. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT RETURNED AND NO ISSUES COULD BE FOUND WITHIN THE MANUFACTURING RECORDS, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE COULD NOT BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE NEED TO REPLACE THREE BLADDER CATHETERS WITH THERMISTOR CH16 REF 81-080416EU IS REPORTED DUE TO REPEATED DEFLATION OF THE BALLOON AND CONSEQUENT DISPLACEMENT OF THE CATHETER. IN ALL CASES, THE CATHETER WAS FOUND OUT OF PLACE WITH THE BALLOON DEFLATED. IT SHOULD BE NOTED THAT THE PROBLEM OCCURRED WITH ONLY ONE PATIENT AND THAT HIM WAS LATER DISCOVERED WITH A URETHRAL STONE, THUS RAISING THE QUESTION OF A CORRELATION WITH THE EVENT THAT OCCURRED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT THE DEVICE WAS UNABLE TO BE RETURNED AS IT HAD BEEN DISCARDED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, (B)(4). THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "THE NEED TO REPLACE THREE BLADDER CATHETERS WITH THERMISTOR CH16 REF 81-080416EU IS REPORTED DUE TO REPEATED DEFLATION OF THE BALLOON AND CONSEQUENT DISPLACEMENT OF THE CATHETER. IN ALL CASES, THE CATHETER WAS FOUND OUT OF PLACE WITH THE BALLOON DEFLATED. IT SHOULD BE NOTED THAT THE PROBLEM OCCURRED WITH ONLY ONE PATIENT AND THAT HIM WAS LATER DISCOVERED WITH A URETHRAL STONE, THUS RAISING THE QUESTION OF A CORRELATION WITH THE EVENT THAT OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663105 FOLEY CATHETER, 400 SERIES 16 FR (+/-0.1C) CATHETER, UPPER URINARY TRACT EYC DEROYAL INDUSTRIES, INC. 81-080416EU 61524385 00749756596664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention