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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the date of event is unknown, and 01 jan 2025 has been used as a placeholder.E1: this complaint was received through: (b)(6).Portfolio sales specialist (b)(6).D4: possible lot# provided: 5782880, d4: possible lot# expiration date: 01 feb 2027, h4: possible lot# device mfg date: 09 feb 2022.Investigation summary: a couple of photos were shared by customer, where an unknown fluid is observed outside the female luer's threads, no additional damage or anomalies are observed.One (1) used.List#: am3127, 11" was returned for evaluation.As returned no physical damage or anomalies were observed.No mating device was returned.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 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.
Event or Problem Description
A complaint was received regarding regards to a 11" (28 cm) appx 1.1ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, clamp, luer lock that experienced leakage.The reporter stated that the leaking came from item: am3127 right where the manifold collars to the extension set which is supposed to be bonded.The collar spins freely in a 360 degree turn where when spinning it., the extension tubing moves with it.They pull another item from inventory to try but was unable to spin the collar.The packaging was discarded.The product is filled with lipids.The status of the product at the time of event was during use on the patient.The device was used anywhere from 4-7pm to 7-8am.Someone became aware when the lipids where leaking from that collar all over the patient's bed when the clinician checked on the patient.The medication involved was smoc (lipids).There was patient involvement, no adverse event and there was delay in therapy.

• 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: 21774344
• Report Number: 9617594-2025-00653
• Device Sequence Number: 8199859
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: POSSIBLE LOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SMOC (LIPIDS) INFUSATE.
• Patient Sex: Unknown