MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number	MC330419
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a used mc330419 transfer set connected to an iv bag and 20 ml bd syringe.The filter was wetted out with prior infusate.The set was leak tested per product specifications.There was leakage from the filter vent.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.A dhr lot # review could not be conducted because no lot number was identified.Additional reporter details: (b)(6).
Event or Problem Description
A second used sample was returned for investigation.This emdr reflects the second testing failure for the second sample.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
• 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: 24264609
• Report Number: 9617594-2026-00073
• Device Sequence Number: 10059261
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: 00887709087552
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: MC330419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/04/2026
• 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: AADS (AMINO ACID PLUS DEXTROSE SOLUTION), MFR UNK; UNSPECIFIED INFUSION PUMP, MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Sex: Unknown