MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.39 ML, PUR YELLOW SMALLBORE EXT SET W/CLAVE¿ CLEAR, 1.2 MICRON; STOPCOCK, I.V. SET

Catalog Number	MC330715
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) used list# mc330715, 9" (23 cm) appx 0.39 ml, pur yellow smallbore ext set w/clave¿ clear, 1.2 micron filter, clamp, luer lock.As received no anomalies were observed.The set was primed as per procedure and a leak from the filter vent hole was confirmed.Complaint of leaks 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 device history report (dhr) lot review was performed and no relevant anomalies, discrepancies or nonconformances were identified that might be relevant with the condition reported by customer.
Event or Problem Description
The event occurred on an unspecified date involving a 9" (23 cm) appx 0.39 ml, pur yellow smallbore ext set w/clave¿ clear, 1.2 micron filter, clamp, luer lock where a leak during patient use was reported.The customer changed the total parenteral nutrition (tpn) and lipids on pm shift.All happened within 1-2hrs of hanging the new bags.No patient was harmed, but it added time and additional resources to change the tubing again and having to change the linen.The leaking occurred at the actual filter site.

• Brand Name: 9" (23 CM) APPX 0.39 ML, PUR YELLOW SMALLBORE EXT SET W/CLAVE¿ CLEAR, 1.2 MICRON
• 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: 23293266
• Report Number: 9617594-2025-01983
• Device Sequence Number: 16000722
• Product Code: FMG
• UDI-Device Identifier: 00887709127197
• UDI-Public: (01)00887709127197(17)290701(10)14081005
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: MC330715
• Device Lot Number: 14081005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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.; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown