BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL MANIFOLD 3 PORT RIGHT HAND, OFF HANDLE LOW PRESSURE

    MDR report key: 22852946 · Received August 20, 2025

    Report

    Report Number
    3004605321-2025-00012
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 15, 2025
    Report Date
    October 14, 2025
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.R.L
    Product Code
    DTL
    UDI-DI
    00749756719919
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED THROUGH MEDWATCH #1423395-2025-00089, "DEFECTIVE MANIFOLD." FOLLOW UP INFORMATION OBTAINED FROM EMAIL ALSO STATED, "SUSPECTED AIR EMBOLISM INTRODUCED THROUGH DEFECTIVE MANIFOLD." THE CUSTOMER REPORTED THAT THERE WAS A "CRACK ON THE END OF THE MANIFOLD WHERE CONNECTING TUBE CONNECTS TO MANIFOLD GOING TO CATHETER". DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT AVAILABLE FOR RETURN. BECAUSE THERE WAS ALSO NO LOT NUMBER PROVIDED WITH THE COMPLAINT, THE SPECIFIC DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE MANUFACTURING AND ASSEMBLY PROCESSES FOR MANIFOLDS AS A WHOLE WERE REVIEWED. SAMPLE UNITS ARE TESTED PRIOR TO ASSEMBLY AND AFTER ASSEMBLY IN INITIAL AND FINAL INSPECTIONS WITH THE FOLLOWING TESTS: VISUAL INSPECTION, TORQUE TEST, VACUUM LEAK TEST, AND HYDROSTATIC TEST. FROM THESE INSPECTIONS NO ISSUES WERE IDENTIFIED. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM JANUARY 2023 TO SEPTEMBER 2025 AND FOUND TO BE 0.0006%. ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT AVAILABLE FOR RETURN AND NO ISSUES COULD BE FOUND WITHIN THE INVESTIGATION, NO ROOT CAUSE COULD BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED THROUGH MEDWATCH #1423395-2025-00089, "DEFECTIVE MANIFOLD." FOLLOW UP INFORMATION OBTAINED FROM EMAIL ALSO STATED, "SUSPECTED AIR EMBOLISM INTRODUCED THROUGH DEFECTIVE MANIFOLD." THE CUSTOMER REPORTED THAT THERE WAS A "CRACK ON THE END OF THE MANIFOLD WHERE CONNECTING TUBE CONNECTS TO MANIFOLD GOING TO CATHETER". DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT AVAILABLE FOR RETURN. 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 DISTRIBUTING FACILITY REPORTED THROUGH MEDWATCH #1423395-2025-00089, "DEFECTIVE MANIFOLD." FOLLOW UP INFORMATION OBTAINED FROM EMAIL ALSO STATED, "SUSPECTED AIR EMBOLISM INTRODUCED THROUGH DEFECTIVE MANIFOLD." THE CUSTOMER REPORTED THAT THERE WAS A "CRACK ON THE END OF THE MANIFOLD WHERE CONNECTING TUBE CONNECTS TO MANIFOLD GOING TO CATHETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155891 DEROYAL MANIFOLD 3 PORT RIGHT HAND, OFF HANDLE LOW PRESSURE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL DEROYAL INTERCONTINENTAL, S.R.L 60-3225 00749756719919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other