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	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 60" (152 cm) pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock and it was reported that lipid tubing was found to be leaking shortly after hanging tubing.There were patient involvement and no patient harm reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.Additional contact information: (b)(6).
Additional Manufacturer Narrative
One used 60" (152 cm) appx 1.4 ml, pur yellow smallbore ext set w/microclave¿ clear, 1.2 micron filter, clamp, luer lock was received for evaluation.Visual inspection and functional testing was carried out.Upon visual inspection the filter was observed to be wetted out.The sample was tested and was primed at gravity pressure with no issues.The sample was pressure leak tested at 25psi with a leak observed from the filter.The reported complaint of a leak could be confirmed.The probable cause is from the temporary loss of hydrophobic properties.D9 - date returned to mfg.:11/24/2025.

• 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: 23640817
• Report Number: 9617594-2025-02214
• Device Sequence Number: 15880894
• Product Code: FMG
• UDI-Device Identifier: 00887709095854
• UDI-Public: 00887709095854
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: MC330472
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/04/2026
• 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: LIPID, UNK MFR
• Patient Sex: Unknown