MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC330523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a 127" (323 cm) appx 9.7 ml, transfer set w/microclave® clear, dual check valve, smallbore clear/pur yellow trifuse ext set w/2 microclave® clear (yellow, green rings), 2-0.2 micron filters, rotating luer where it was reported green filter was leaking during infusion.There was patient involvement, and no adverse event/serious harm reported.This report captures 2 occurrences.
Additional Manufacturer Narrative
The customer provided the following for complaint investigation: one used list# mc330523, 127" (323 cm) appx 9.7 ml transfer set w/clave¿ clear, dual check valve, smallbore trifuse ext set w/1 pur yellow, 2 clave¿ clear (yellow, green rings), 2-0.2 micron filters, spin luer; lot# 14096986.No damages or anomalies were observed on the returned used device.The reported complaint of a leak from the green filter was not confirmed.The returned sample was tested and met product specifications.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 127" (323 CM) APPX 9.7 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: 20813870
• Report Number: 9617594-2024-01713
• Device Sequence Number: 9934345
• Product Code: FMG
• UDI-Device Identifier: 00887709092020
• UDI-Public: (01)00887709092020(17)290801(10)14096986
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: MC330523
• Device Lot Number: 14096986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/30/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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 Sex: Unknown