MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L DEROYAL MANIFOLD 3 PORT RIGHT HAND, OFF HANDLE LOW PRESSURE; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	60-3225
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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".
Additional Manufacturer Narrative
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.

• Brand Name: DEROYAL MANIFOLD 3 PORT RIGHT HAND, OFF HANDLE LOW PRESSURE
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22852946
• Report Number: 3004605321-2025-00012
• Device Sequence Number: 18243597
• Product Code: DTL
• UDI-Device Identifier: 00749756719919
• UDI-Public: 00749756719919
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60-3225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown