MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L 3 PORT MANIFOLD KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	35-401106
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A user facility reported, "customer notes they were injecting using high pressure and it leaked.".
Additional Manufacturer Narrative
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.

• Brand Name: 3 PORT MANIFOLD KIT
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC..; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22639306
• Report Number: 3005011024-2025-00009
• Device Sequence Number: 9563971
• Product Code: OEQ
• UDI-Device Identifier: 00749756371803
• UDI-Public: 00749756371803
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: ENFDISC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35-401106
• Device Lot Number: 61104305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown