MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 1.4 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, 1.2; STOPCOCK, I.V. SET

Catalog Number	MC330472
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.A device history review could not be completed due to the unknown lot number.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on an unspecified date and involved a 60" (152 cm) appx 1.4 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock.It was reported that they have a patient that is running parenteral nutrition utilizing our infusion products.They are experiencing an allergic reaction each day shortly after starting the infusion, which resolves with treatment and does not return despite continuing this infusion.No noted product defects upon opening/unopened.There was patient involvement and patient harm.

• Brand Name: 60" (152 CM) APPX 1.4 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: 23613389
• Report Number: 9617594-2025-02199
• Device Sequence Number: 9971506
• Product Code: FMG
• UDI-Device Identifier: 00887709095854
• UDI-Public: 00887709095854
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MC330472
• Device Lot Number: UNKNOWN
• 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: 11/05/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PARENTERAL NUTRITION, UNK MFR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown