MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 C; STOPCOCK, I.V. SET

Catalog Number	A1145
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 12" smallbore hexafuse ext set w/6 microclave clear, nanoclave (red ring), 6 check valves, 7 clamps (green, 2 yellow, blue, light green, 2 white) luer lock that experienced leakage during use.The reporter stated that the rn was hanging new tpn/smof/fentanyl/precedex into picc line.After hanging the lines and before fluids were started, this rn noticed that fentanyl syringe was cloudy and noticed tubing was backed with smof lipids regardless of the hexset being clamped.This rn then noticed that smof was leaking into other areas of the hexset and fluids were not started as result.New bags were ordered and hung.Patient involved is a 0.05-year-old male.No other devices being use on the patient at the time of the event that may have cause or contributed to the event.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
A2 - date of birth - the patients age was reported as 0.05-years, which was used to approximate the date of birth as (b)(6) 2025.Investigation summary one (1) used.List #a1145, 12"and two (2) used.List #unknown, extension set w/ clave were returned for evaluation.As returned some tpn/smof/fentanyl/precedex solution residuals was observed.No additional damage or anomalies.The set and the unknown extension sets were primed, and no occlusion, leaks or anomalies were noted.The backflow resistance of each valve backcheck was tested as per procedure and a backflow on 2 out 6 was confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Complaint of smof was leaking into other areas can be confirmed.The probable cause was due to an ensenada's vendor issues on valve backcheck.

• Brand Name: 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 C
• 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: 22120419
• Report Number: 9617594-2025-01133
• Device Sequence Number: 17931345
• Product Code: FMG
• UDI-Device Identifier: 00887709070103
• UDI-Public: (01)00887709070103(17)291001(10)14189092
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2025

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: A1145
• Device Lot Number: 14189092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: PICC LINE, MFR UNKNOWN; TPN/SMOF/FENTANYL/PRECEDEX, MFR UNKNOWN
• Patient Age: 19 DA
• Patient Sex: Male