MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.55 ML, SMALLBORE EXT SET W/CLAVE¿ CLEAR, 0.2 MICRON FILTER,; STOPCOCK, I.V. SET

Catalog Number	MC330713
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
Event or Problem Description
On an unspecified date, a 60" (152 cm) appx 0.55 ml, smallbore ext set w/clave¿ clear, 0.2 micron filter, clamp, luer lock was reportedly leaking an unspecified infusate.There was no report of any human harm.
Additional Manufacturer Narrative
One used list # mc330713 connected to 0.9% sodium chloride injection 10ml syringe were returned for evaluation.As received, no anomalies were observed.The set was primed as per procedure and a leak from the filters vents was confirmed.Complaint of leak 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.A dhr lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 60" (152 CM) APPX 0.55 ML, SMALLBORE EXT SET W/CLAVE¿ CLEAR, 0.2 MICRON FILTER,
• 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: 23368144
• Report Number: 9617594-2025-02029
• Device Sequence Number: 8870378
• Product Code: FMG
• UDI-Device Identifier: 00887709126916
• UDI-Public: 00887709126916
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: MC330713
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/23/2025
• 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: UNSPECIFIED FLUID/INFUSATE, MFR UNK
• Patient Sex: Unknown