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/CLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBO; SET, ADMINISTRATION, INTRAVASCULAR

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	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 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 generated a leak during patient use.The report stated, "trifuse extension set was leaking at the 0.2 micron filter on the green ring lumen." a sample is available for investigation.There was no patient harm reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one (1) 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 #unknown.The filter was observed to be wetted out.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed on the in-line filter.The probable cause of the leak is from the temporary loss of hydrophobic properties.A device history lot # review could not be conducted because no lot number(s) was/were identified.Updated information in section e.

• Brand Name: 127" (323 CM) APPX 9.7 ML TRANSFER SET W/CLAVE¿ CLEAR, DUAL CHECK VALVE, SMALLBO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22562440
• Report Number: 9617594-2025-01512
• Device Sequence Number: 3994245
• Product Code: FPA
• UDI-Device Identifier: 00887709092020
• UDI-Public: 00887709092020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100434
• 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): 09/11/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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