MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 1.4 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 0.2 MI; STOPCOCK, I.V. SET

Catalog Number	MC33928
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An incident involving 7" (18 cm) appx 1.4 ml, smallbore quadfuse ext set w/4 microclave® clear, 0.2 micron filter, 3 check valves, 4 clamps, rotating luer reported that 4-way connector was leaking at filter and standard concentration tubing leaking at filter (antiarrhythmic drugs line).There was unknown patient involvement and unknown harm/adverse event reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.Additional contact information: (b)(6).(b)(6) hospital.
Additional Manufacturer Narrative
D9 - device available for evaluation: no additional information in b5.
Event or Problem Description
Additional information received stating that there was patient involvement but no patient harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.A device history review could not be completed due to the unknown lot number.

• Brand Name: 7" (18 CM) APPX 1.4 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 0.2 MI
• 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: 23566260
• Report Number: 9617594-2025-02172
• Device Sequence Number: 10120599
• Product Code: FMG
• UDI-Device Identifier: 00887709072220
• UDI-Public: 00887709072220
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: MC33928
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 12/19/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/18/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 LINE, UNK MFR.
• Patient Sex: Unknown