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	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 11" (28 cm) appx 1.1ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, luer lock that experienced leakage.The reporter stated that they had encountered leaking from the exact spot of where the collar bonds onto the extension set of the set while they were infusing lipids.It was also stated that the only difference was they were unable to spin the collar and it was just leaking.It was also stated that it was used throughout the night after hanging fluids.The event date occurred on (b)(6) 2025 during infusion.Sample photo was provided showing the defective product that leaked.Thus, there was patient involvement, no human harm and there was delay in therapy reported.
Additional Manufacturer Narrative
Investigation summary a series of photos were shared by customer, where customer is indicating on a blue circle the defective area, where an unknown fluid is observed coming from inside the female luer's threads, no additional damage or anomalies are observed.One (1) used.List #am3127, connected to an used.List #unknown, extension tubing with filter and clave and one used.List #unknown, yellow extension tubing with filter and clave were returned for evaluation.As received no physical damage or anomalies was 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.A device history record lot # review could not be conducted because no lot number(s) was/were identified.Complaint of leaks can be confirmed based on the physical used sample evaluation.The probable cause was due to an incomplete insertion during manual process assembly in ensenada.

• 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: 21922534
• Report Number: 9617594-2025-00856
• Device Sequence Number: 9031423
• Product Code: FMG
• UDI-Device Identifier: 00887709122949
• UDI-Public: 00887709122949
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: AM3127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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