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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, it is not yet received.
Event or Problem Description
The event involved a 60" smallbore ext set w/microclave® clear, clamp, luer lock where the customer reported that micro tubing or med tubing was found to have a leak while setting up lines.The device was being used for patient care.There were no other devices being used on the patient at the time of the event that may have caused or contributed to the event.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Received one used mc33352 smallbore ext set w/microclave for inspection.No defects or anomalies noted.The set was leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 5/16/2025.

• 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: 22040626
• Report Number: 9617594-2025-01046
• Device Sequence Number: 8781296
• Product Code: FMG
• UDI-Device Identifier: 00887709038004
• UDI-Public: (01)00887709038004(17)290401(10)13962869
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: MC33352
• Device Lot Number: 13962869
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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 Age: 11 MO
• Patient Sex: Male