MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L MANIFOLD 2 PORT RIGHT HAND, ROTATING ADAPTOR OFF; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	60-2225
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "we had an issue with a manifold leaking.It appears that there is a crack in it.I am not sure if it was there or happened when we connected it.Incident happened during use in a procedure performed in ireland.".
Additional Manufacturer Narrative
A user facility reported, "we had an issue with a manifold leaking.It appears that there is a crack in it.I am not sure if it was there or happened when we connected it.Incident happened during use in a procedure performed in ireland." deroyal industries, inc.Requested return of the device; however, it has not yet been received.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.

• Brand Name: MANIFOLD 2 PORT RIGHT HAND, ROTATING ADAPTOR OFF
• 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): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 24835214
• Report Number: 3004605321-2026-00001
• Device Sequence Number: 10305855
• Product Code: DTL
• UDI-Device Identifier: 00749756719780
• UDI-Public: 00749756719780
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 60-2225
• Device Lot Number: 62722578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/26/2026
• 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