MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 0.2 MICRON FILTER, 2 CHECK; STOPCOCK, I.V. SET

Catalog Number	MC33927
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 6.5" smallbore trifuse ext set w/3 microclave® clear, 0.2 micron filter, 2 check valves, 3 clamps, rotating luer.The 3-way filter was found to be leaking at approx.2225, aads (central venous catheter, cvc) line was reportedly leaking at approx 0520, then a new 3 way filter was started at 2250 filter was found leaking at approx 0610.Total parenteral nutrition (tpn) was running at the time of the complaint/event.There was no adverse event/serious harm reported.
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.Additional contact information: (b)(4).

• Brand Name: 6.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 0.2 MICRON FILTER, 2 CHECK
• 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: 21586995
• Report Number: 9617594-2025-00459
• Device Sequence Number: 8895927
• Product Code: FMG
• UDI-Device Identifier: 00887709072213
• UDI-Public: 00887709072213
• 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
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: MC33927
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK; UNSPEC AADS OR CENTRAL VENOUS CATH CVC, MFT UNK
• Patient Sex: Unknown