MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	MC330027
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
An event involving a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock reported that the patient receiving fluids and meds through a trifuse tubing adaptor and it started to leak profusely.Patient was receiving lactated ringers (lr) maintenance fluids and lacosamide for seizures.Small amount of fluid/medication lost due to leakage and volume replacement.Potential for a lower seizure threshold due to underdose of scheduled seizure med because of leakage.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9 - date returned to mfr: 2/26/2026.Received one (1) used 7" (18 cm) smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, luer lock.Unknown lot #.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was tested and a leak was observed at the connection of the tubing and the male luer.A small tear was observed on the tubing at the luer connection.The probable cause of the leak is from an unintentional pulling force during use.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM
• 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: 24412573
• Report Number: 9617594-2026-00166
• Device Sequence Number: 10527029
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: 00887709076419
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: MC330027
• Device Lot Number: UNKNOWN
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: LACOSAMIDE, UNK MFR; LACTATED RINGERS, UNK MFR
• Patient Sex: Unknown