MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GL; STOPCOCK, I.V. SET

Catalog Number	MC33193
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, however, a device history will be reviewed.
Event or Problem Description
The event involved a 7" (18 cm) appx.0.7 ml smallbore trifuse ext set w/3 microclave® clear (red, glow rings), 0.2 micron filter, 3 clamps (red, white, blue), rotating luer where the customer reported that the product was leaking from the filter, while connected to the picc line on a patient.Harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.A lot history review could not be conducted as no lot information was provided.

• Brand Name: 7" (18 CM) APPX. 0.7 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR (RED, GL
• 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: 21997882
• Report Number: 9617594-2025-00974
• Device Sequence Number: 21016136
• Product Code: FMG
• UDI-Device Identifier: 00887709057616
• UDI-Public: (01)00887709057616(17)280701(10)13709042
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: Other
• Device Catalogue Number: MC33193
• Device Lot Number: 13709042
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: PERIPHERALLY INSERTED CENTRAL CATHETER, PICC, UNK.
• Patient Sex: Unknown