MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) APPX 0.67 ML, SMALLBORE EXT SET W/REMV CHECK VALVE, 0.2 MICRON FILTE; STOPCOCK, I.V. SET

Catalog Number	Z3994
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 12" (30 cm) appx 0.67 ml, smallbore ext set w/remv check valve, 0.2 micron filter, clamp, luer lock where it was reported an infant was on a fentanyl drip.There were very small droplets dripping out of the tubing just below the stopcock.Additionally, it was stated that the tubing must have a crack in the line.There event happened in the neonatal intensive care unit (nicu).There was patient involvement, and no harm reported.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed from the photo provided.Without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.

• Brand Name: 12" (30 CM) APPX 0.67 ML, SMALLBORE EXT SET W/REMV CHECK VALVE, 0.2 MICRON FILTE
• 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: 22059435
• Report Number: 9617594-2025-01067
• Device Sequence Number: 7812475
• Product Code: FMG
• UDI-Device Identifier: 00887709070745
• UDI-Public: 00887709070745
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: Z3994
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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: FENTANYL DRIP, UNK MFR.
• Patient Sex: Unknown