MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GL; STOPCOCK, I.V. SET

Catalog Number	MC33193
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Sepsis (2067); Ventilator Dependent (2395)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 7" (18 cm) appx.0.7 ml smallbore trifuse ext set w/3 microclave® clear (red, glow rings), 0.2 micron filter, 3 clamps (red, white, blue), rotating luer.The device was reportedly leaking total parenteral nutrition from the device's filter.The fluid consistently leaked only at the filter location.A sepsis diagnosis and declining status occurred after the leaking items were found and the patient required intubation with conventional ventilation and that ultimately escalated to high frequency ventilation.A full sepsis work up including sputum culture, urine culture, blood culture, lumbar puncture was ordered and performed.They stopped the patient's parenteral feedings/optimal nutrition because many labs and multiple xrays were required to identify infection and monitor the patient's status and progression.Further medical intervention included medication drips to support blood pressure and the initiation of antibiotic therapy.The cracks or breaks were not visible.The issue was noted after the devices were connected to the patient.Fluids/meds were being infused when the linens and tubing were noted to be wet.The infant became extremely sick and septic.Although there was patient harm, there was no delay in therapy or any missed medication doses.
Additional Manufacturer Narrative
Received one (1) used list# mc9013, 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer for inspection.The inlet and outlet filter vents on the 0.2 micron appeared to be intact.The set was leak-tested per product specifications.There was leakage from the inlet filter vent on the 0.2 micron filter.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 leaking air vent filter is believed to not have been a point of entry for anything to enter the fluid path.The air vent material itself is a polytetrafluoroethylene (ptfe) membrane with a pore size of 0.02 microns and although the membrane was found to be leaking fluid, it was not found to be damaged and is believed to still act as a sterile barrier.Further, the air vent filters are proximal to the inline 0.2 micron filter and any particulates or bacteria would have to flow past this 0.02 miron ptfe membrane would also need to flow past the in-line 0.2 micron filter, which was found to be intact and not damaged.This loss of hydrophobic properties on the air vent is believed to not have contributed to the resulting sepsis diagnosis and declining status which occurred after the leaking items were found.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GL
• 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: 21914215
• Report Number: 9617594-2025-00846
• Device Sequence Number: 17958698
• Product Code: FMG
• UDI-Device Identifier: 00887709057616
• UDI-Public: 00887709057616
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC33193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.; UNSPECIFIED FLUIDS, MFR UNK.; UNSPECIFIED MEDICATIONS, MFR UNK.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown