MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC330310
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- the investigation is pending.
Event or Problem Description
The event involved a 14" (36 cm) ext set w/1.2 micron filter, microclave® clear, clamp, rotating luer where a report stated that parts of the lipid line tubing breaking or leaking.The rn found lipid tubing at site near filter disconnected and broken off.Lipids were continuing to run but not going to patient.When found, lipids stopped, and the rest of the line was disconnected from the patient.There was patient involvement and no patient harm, but all patients did not receive their full doses of prescribed lipids.
Additional Manufacturer Narrative
Received one used list# unknown, 250ml iv bag; lot# unknown --> one (1) used list# unknown, infusion set; lot# unknown --> one (1) used list# mc330310, 14" (36 cm) ext set w/1.2 micron filter, microclave¿ clear, clamp, rotating luer; lot# unknown.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed at the inlet filter.The probable cause of the leak is from the temporary loss of hydrophobic properties during use.A device history report (dhr) lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14" (36 CM) EXT SET W/1.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• 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: 21128693
• Report Number: 9617594-2025-00058
• Device Sequence Number: 6807179
• Product Code: FMG
• UDI-Device Identifier: 00887709083189
• UDI-Public: 00887709083189
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: MC330310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS, MFR UNK.
• Patient Sex: Unknown