MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC33332
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.D4: only di provided as lot number is unknown.
Event or Problem Description
An event involving a 128" (325 cm) appx 9.3 ml, transfer set w/microclave clear, dual check valve, smallbore bifuse ext set w/microclave clear (green ring), 0.2 micron filter, rotating luer was reported that the products were leaking at the bag spike.They noted puddle on ground and wet tubing.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary two (2) used.List # mc33332, lot #unknown connected to two (2) used.List # z2133, lot #unknown and a bd needleless connector and bd 50ml and 30ml syringes were returned for evaluation.As received no physical damage or anomalies only unknown residual solution.The sets were tested as returned and a leaks from the filters vent hole and the filter vent at the spikes were observed.Complaint of leaks can be confirmed.The probable cause is typically due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.A device history lot # review could not be could not be conducted because no lot number(s) was/were identified.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 24543225
• Report Number: 9617594-2026-00239
• Device Sequence Number: 9377908
• Product Code: FMG
• UDI-Device Identifier: 00887709037816
• UDI-Public: 00887709037816
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: MC33332
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• 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
• Patient Sex: Unknown