MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	MC3302
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
An email was received regarding an 7" (18 cm) appx 0.24 ml, smallbore ext set with microclave¿ clear, clamp, rotating luer was able to pull on an intravenous (iv) connector by an animated child, which led to device failure.The welded injection valve separated from the tubing and allowed bleeding.The connector was replaced and the iv was not dislodged.There was no delay in therapy.The product was contaminated with blood.There was patient involvement and no harm.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• 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: 25107333
• Report Number: 9617594-2026-00434
• Device Sequence Number: 10744948
• Product Code: FMG
• UDI-Device Identifier: 00887709037267
• UDI-Public: (01)00887709037267(17)300901(10)14567064
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: MC3302
• Device Lot Number: 14567064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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