BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 PORT MANIFOLD KIT

    MDR report key: 22639306 · Received July 28, 2025

    Report

    Report Number
    3005011024-2025-00009
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 25, 2025
    Report Date
    August 4, 2025
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.R.L
    Product Code
    OEQ
    UDI-DI
    00749756371803
    PMA / PMN Number
    ENFDISC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "CUSTOMER NOTES THEY WERE INJECTING USING HIGH PRESSURE AND IT LEAKED.". DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE AND RECEIVED IT ON 7/22/2025. DEROYAL REVIEWED THE DEVICE HISTORY RECORD (DHR) AND FOUND NO DISCREPANCIES WITHIN THE MANUFACTURING OR ASSEMBLY PROCESS. THE VISUAL INSPECTION AND FUNCTIONAL TESTING WERE ALSO REVIEWED WITHIN THE DHR. THE VISUAL INSPECTION, TORQUE TEST, VACUUM LEAK TEST AND HYDROSTATIC TEST WERE ALL REVIEWED FOR THE LOT PROVIDED AND EACH WERE WITHIN THE RESPECTIVE SPECIFICATIONS. THE HYDROSTATIC TEST WAS PERFORMED ON THE SAMPLE RETURNED AND NO DISCREPANCIES WERE FOUND WITHIN THE SPECIFICATION. NO LEAKS WERE FOUND WITHIN THE TOLERANCE FOR LOW PRESSURE MANIFOLDS. THE IFU WAS REVIEWED AND CONFIRMED TO STATE THAT LOW PRESSURE MANIFOLDS HAVE A MAXIMUM PRESSURE RATING OF 250 PSI. DEROYAL CONDUCTED A COMPLAINT TO SALES RATIO FROM FEBRUARY 2023 TO JUNE 2025 AND FOUND NO OTHER SIMILAR COMPLAINTS. THE COMPLAINT TO SALES RATIO WAS FOUND TO BE (B)(4). ROOT CAUSE: THE INVESTIGATION DID NOT SHOW ANY DISCREPANCIES WITHIN INSPECTION OR FUNCTIONAL TESTING IN THE DEVICE HISTORY RECORD OR WHEN REVIEWED ON THE RETURNED SAMPLE. BECAUSE OF THIS AND THE FACT THAT THE COMPLAINT STATED THAT THE CUSTOMER WAS USING HIGH PRESSURE, THE ROOT CAUSE HAS BEEN DETERMINED TO BE USER ERROR. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR AND LABELING WAS REVIEWED AND FOUND TO LIST THE CORRECT PRESSURE SPECIFICATIONS, 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, "CUSTOMER NOTES THEY WERE INJECTING USING HIGH PRESSURE AND IT LEAKED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE AND RECEIVED IT ON 7/22/2025. THE 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, "CUSTOMER NOTES THEY WERE INJECTING USING HIGH PRESSURE AND IT LEAKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622588 3 PORT MANIFOLD KIT ANGIOGRAPHY/ANGIOPLASTY KIT OEQ DEROYAL INTERCONTINENTAL, S.R.L 35-401106 61104305 00749756371803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown