MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Catalog Number	AM3127
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation has not yet been completed.
Event or Problem Description
The event occurred on an unspecified date and involved a 11" (28 cm) appx 1.1ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, clamp, luer lock.The customer reported that the patient had a peripheral intravenous line (piv) and smoc lipids infusing when the nurse noticed the patient¿s linens were soaked.The leak appeared to come from the collar and extension bond of the set.When they changed and ran a single line, they noticed there was no leaking.It was in use throughout the night after hanging fluids the day before.They went back to infusing through the manifold and then noticed the leaking.There was patient involvement, no adverse event and there was delay in therapy.There were 4 instances reported on unspecified dates.
Additional Manufacturer Narrative
Received one new device for evaluation along with one used 50 ml bd syringe and one used yellow tubing with filter; as received, no physical damage or other anomalies observed.The sample was tested according to procedure and a leak from between adaptor and nanoclave manifold body's thread was observed, no additional leak was observed along the set.Complaint of leaking from the collar and extension bond of the set can be confirmed based on the physical used sample evaluation.The probable cause was due to an incomplete insertion during manual process assembly during manufacturing.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA
• 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: 21978285
• Report Number: 9617594-2025-00928
• Device Sequence Number: 20649271
• Product Code: FMG
• UDI-Device Identifier: 00887709122949
• UDI-Public: (01)00887709122949(17)270201(10)5782880
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/16/2025

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: AM3127
• Device Lot Number: 5782880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: SMOC (LIPIDS)
• Patient Sex: Unknown