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	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
The device has been received for evaluation and investigation is underway but is not yet complete.
Event or Problem Description
The event occurred on unspecified dates between 02-dec-2024 and 13-jan-2025 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.The customer reported that the device was leaking lipids.There was patient involvement, a delay in therapy due to changing or having to remove the drip altogether but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: five used list# mc330472, 60" (152 cm) appx 1.4 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock (2 of them were connected to each other).One used unknown, 120ml iv bag connected to an unknown, infusion set with filter.One used unknown, infusion set with filter.One used unknown, bd 1ml syringe connected to an unknown, extension set with filter.As received, there was no physical damage and no anomalies on the samples.The five samples were tested as per procedure and leaks through the filter vent in 3 out 5 samples were confirmed.No additional leaks was observed.The complaint of leakage 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, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in h6 health effect - impact code and e3 - initial reporter occupation.

• 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: 21360741
• Report Number: 9617594-2025-00268
• Device Sequence Number: 8451898
• Product Code: FMG
• UDI-Device Identifier: 00887709095854
• UDI-Public: (01)00887709095854(17)280801(10)13739478
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: MC330472
• Device Lot Number: 13739478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: LIPIDS, MFR UNK
• Patient Sex: Unknown