MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Event or Problem Description
The event was reported via a medwatch report # (b)(4) (attached).The report stated "single lumen picc [peripherally inserted central catheter] was infusing ampicillin.Tech called rn to bedside for blood coming out of picc.Nurse paused fluids and checked line.Trifuse extension appeared to have a leak.Blood had back up and was leaking out of trifuse extension.Manufacturer response for extension set, 9.5¿ 1.4 smallbore trifuse set, 3 microclave clear, nanoclave, 3 check valves (per site reporter).Yes, they were made aware on [date redacted].Currently awaiting manufacturer response." additional event information obtained from ufmw: the report was completed by (b)(6) a risk manager of (b)(6) hospital.The date of this report was on jul-2025.This is a product problem with the event date jun-2025.The outcome attributed to adverse event other serious or important medical events.The age of the patient is 13 days old.The suspected device is a 9.5" (24 cm) smallbore trifuse ext set w/3 microclave® clear, nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock with list number a1141 and unknown lot number with procode fmg, common device name.This is not single-use device that was reprocessed and reused on a patient.This device was not serviced by a third-party service.Sample was available for evaluation.This is an initial type of report.The location where event occurred was in hospital¿s patient room.The report was sent to the manufacturer.The type of reportable event is malfunction.There was patient involvement and unknown adverse event.Cliporgo (b)(6) 2026.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 22947938
• Report Number: 9617594-2025-01784
• Device Sequence Number: 9257166
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: 00887709069343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: A1141
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/02/2025
• 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: AMPICILLIN
• Patient Age: 13 DA
• Patient Sex: Unknown