MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Pneumocephalus (4587)
Date of Event	01/17/2026
Type of Reportable Event	Death
Event or Problem Description
The event involved a 9.5" smallbore trifuse ext set w/3 microclave® clear,nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock.The report stated that code event in 1900, with return of spontaneous circulation (rosc) achieved after approximately 15.Following resuscitation, air bubbles were noted in the iv tri-set distal to the red port where code medications had been administered.A head ultrasound revealed pneumocephalus, and telemetry review was suspicious for a coronary event.The peripherally inserted central catheter (picc) dressing was taken down, and the entire line setup was changed.Notably, a cap and line change had been performed approximately 50 minutes prior to the arrest.The patient passed away after the event.It was unclear if any interventions were due to the event, and the issue currently remains under investigation.No additional information is available at this time.Note: the specific date of death is unknown but it occurred on or after (b)(6) 2026.
Additional Manufacturer Narrative
Complaint investigation activities are pending at this time.Additional related report number: 9617594-2026-00063-00.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.No lot number was provided for a lot history review.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review (dhr) could not be reviewed due to the unknown lot number.
Additional Manufacturer Narrative
Correction: after further review and customer confirmation it has been determined that this record, mfr mdr # 9617594-2026-00064, is a duplicate of mfr mdr report # 9617594-2026-00104.Please consider this record, 9617594-2026-00064, void.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 24258186
• Report Number: 9617594-2026-00064
• Device Sequence Number: 15456241
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: 00887709069343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1141
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 03/20/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/15/2026
• 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: 60" SMALLBORE EXT SET W/MICROCLAVE, MFR ICU MED; PICC WITH DRESSING, MFR UNK; UNSPECIFIED CODE MEDICATIONS, MFR UNK
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Sex: Unknown