MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183 CM) APPX 1.7 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2; STOPCOCK, I.V. SET

Catalog Number	MC330217
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to a yellow smallbore ext set with microclave clear, 1.2 micron filter, clamp, luer lock in which is was reported that there was leakage during patient use on an unknown date.It was reported that registered nurse started assessment and changing out linen.While holding the patient, it was noticed that lipids running through the picc line were leaking from the filter port.All connections below were checked including trifuse and claves were found to all be secure and tight.When putting gloved hand underneath lipid filter, drops of lipids were noted.There was patient involvement and there was patient harm.
Additional Manufacturer Narrative
E1 additional contact: (b)(6).The device has been requested for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
Additional information b5 section.
Event or Problem Description
Additional information was received stating that there was patient involvement, but no patient harm associated with this event.
Additional Manufacturer Narrative
One (1) used.List #mc330217, 72" (183 cm) appx 1.7 ml, pur yellow smallbore ext set w/microclave¿ was returned for evaluation.As received the filter vent looks to be a wetted out, beside that no physical damage were noted or additional anomalies were observed.The set was primed as per procedure and no leaks were confirmed.Even complaint of leak was not able to be replicated, based on the wetted out condition observed on the filter vent as returned, complaint can be confirmed.The probable cause is typical due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 72" (183 CM) APPX 1.7 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2
• 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: 23872708
• Report Number: 9617594-2025-02326
• Device Sequence Number: 14784815
• Product Code: FMG
• UDI-Device Identifier: 00887709080638
• UDI-Public: (01)00887709080638(17)290801(10)14104662
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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 Catalogue Number: MC330217
• Device Lot Number: 14104662
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/05/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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