MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.21 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC33902
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a 7" (18 cm) appx 0.21 ml, smallbore ext set w/microclave® clear, clamp, luer lock where the customer reported leaking between the extension and the pigtail.The pigtail was replaced but leaking was still noted.The link on the extension set was not able to be removed so the entire extension set needed to be removed.In the process of replacement, the iv catheter came out which needed to be replaced.The reporter added that the patient's blood sugar at that time was low (specific information not provided).There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for evaluation, however, a lot history review should be performed.Additional reporter information: (b)(6).
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Lot history review was conducted, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.21 ML, 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: 23739366
• Report Number: 9617594-2025-02261
• Device Sequence Number: 8835784
• Product Code: FMG
• UDI-Device Identifier: 00887709071124
• UDI-Public: (01)00887709071124(17)291001(10)14176488
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: MC33902
• Device Lot Number: 14176488
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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