MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC33352
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
Additional Manufacturer Narrative
Complaint investigation activities are pending at this time.
Event or Problem Description
The event involved a 60" smallbore ext set w/microclave® clear, clamp, luer lock.The reporter stated that an air pocket was visualized in the lipid infusion line near the connection site during patient use, raising concern for a possible air embolism.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 and preserved.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
Corrected information can be found in: -d10 - concomitant products.-e4 - initial report sent to fda.-h10 - related report numbers.H11 - additional mfg narrative: additional related report number: 9617594-2026-00064-00.
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.

• Brand Name: 60" SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK
• 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: 24257740
• Report Number: 9617594-2026-00063
• Device Sequence Number: 7976173
• Product Code: FMG
• UDI-Device Identifier: 00887709038004
• UDI-Public: 00887709038004
• 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): 03/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC33352
• 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: 01/19/2026; 03/13/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/04/2026; 03/20/2026
• 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: (LIPID) INFUSION LINE, MFR UNK; (LIPID) INFUSION LINE, MFR UNK; 9.5" SMALLBORE TRIFUSE EXT SET, 3 MICROCLV ICU MED; PICC WITH DRESSING, MFR UNK; PICC WITH DRESSING, MFR UNK
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Sex: Unknown