MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAMP, LUER LOC; STOPCOCK, I.V. SET

Catalog Number	AM3007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a 10" smallbore ext set w/3-port nanoclave¿ manifold, check valve, clamp, luer lock that experienced leakage.The reporter stated that tubing leaked while connected to patient.The event date was on 11-jun-2025 occurred during infusion.This was not detected prior to direct patient use.There is one involved problematic device.Medications involved are tpn, lipids, dopamine and fentanyl.The fused part of the tubing (after manifold) that connects to the line was leaking fluid from the area that is bonded together.The device was changed out/replaced with no further problems encountered.The involved device is available to be tested.There was patient involvement, no serious injury or death, no blood loss, no delay in critical therapy, no adverse operator consequences and no med/surg intervention required.
Additional Manufacturer Narrative
Updated information: d9.Investigation summary.The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history record was reviewed, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 10" SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, CLAMP, LUER LOC
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22475789
• Report Number: 9617594-2025-01436
• Device Sequence Number: 8669315
• Product Code: FMG
• UDI-Device Identifier: 00887709083349
• UDI-Public: (01)00887709083349(17)271001(10)11001827
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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 Catalogue Number: AM3007
• Device Lot Number: 11001827
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DOPAMINE AND FENTANYL, MFR UNKNOWN.; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown