MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE; STOPCOCK, I.V. SET

Catalog Number	MC330716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a smallbore transfer set, and upon investigation of the device, leakage of infusate was identified.There was patient involvement, and no harm/adverse event reported.This event captures second of the returned five devices.
Additional Manufacturer Narrative
One used ext bifuse sets and various mating devices for inspection.Upon visual inspection, the filters were wetted out, and the reported complaint of leakage can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The dfu (directions for use) states: "ivfe or tna (3-in-1) solutions containing lipids must be administered using a 1.2-micron filter.Sets with these filters should be changed at least every 24-hours." a device history review could not be completed due to the unknown lot number.D4: only di provided as lot number is unknown.Additional contact information / distributor (b)(4).

• Brand Name: 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE
• 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: 24556290
• Report Number: 9617594-2026-00248
• Device Sequence Number: 15826500
• Product Code: FMG
• UDI-Device Identifier: 00887709127364
• UDI-Public: 00887709127364
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: MC330716
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/10/2026
• 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: "AADS", UNK MFR.
• Patient Sex: Unknown