MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.3 ML, SMALLBORE EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAMP, ROTAT; STOPCOCK, I.V. SET

Catalog Number	MC3302R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Extension: (b)(4).The device is not available to be returned for evaluation, however, a lot history review should be conducted.
Event or Problem Description
The event occurred on an unspecified date and involved a 7" (18 cm) appx 0.3 ml, smallbore ext set w/remv microclave¿ clear, clamp, rotating luer where the customer reported that there was a slight leak at the extension connection.The customer stated that although the leak was very minor, it posed safety risks.The customer had to change the line because they thought there was a problem with the main line, only to eventually find out that it was the extension.There was a patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Investigation summary.A couple of photos were shared by customer, where customer is showing the item and lot information from the affected item.However, no additional damage or anomalies were noted.Complaint of leaks cannot be confirmed based on the evidence shared by customer.The device history was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 7" (18 CM) APPX 0.3 ML, SMALLBORE EXT SET W/REMV MICROCLAVE¿ CLEAR, CLAMP, ROTAT
• 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: 24149233
• Report Number: 9617594-2026-00031
• Device Sequence Number: 8887421
• Product Code: FMG
• UDI-Device Identifier: 00887709037274
• UDI-Public: (01)00887709037274(17)300301(10)14341304
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: MC3302R
• Device Lot Number: 14341304
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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