MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	AM6152
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot is unknown.The device is not available for investigation.A supplemental mdr will be submitted if any updates become available.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The incident was reported by (b)(6) hospital.The event involved 20 inch (51 cm) appx 1.9 ml, ext set, smallbore w clave clear, 2 6-port nanoclave manifolds, 2 check valves, spin luer with list number am6152 and lot number unknown: it was reported that the patient transferred from outside hospital and placed on all of their hospital drips and drips cocktailed through 12 port manifold.Product noted to be leaking in bed by night shift registered nurse.Patient since transferred was having issues with blood pressure and originally was thought to be a central line issue but since product was changed patient has not had any vital issues.Registered nurse reported leak to occur at bonded port attaching the tubing closest to the patient to the ported microclaves.This exact location for leaking has been a recurrent theme and must be escalated due to the severity of impact and risk caused to patient.Increased risk for clabsi duet to open system in central line.Patient hemodynamically unstable since admission and planned or on (b)(6) 2026.The medication administration to patient got delayed.The following medications like precedex, epinephrine, dilaudid, vasopressin, carrier solution were used in the event.Sample photo is provided for evaluation.There were a patient involvement and patient harm.

• Brand Name: 20" (51 CM) APPX 1.9 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, 2 6-PORT NANOCLAVE¿
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25463087
• Report Number: 9617594-2026-00579
• Device Sequence Number: 18665907
• Product Code: FMG
• UDI-Device Identifier: 00887709122420
• UDI-Public: (01)00887709122420
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: AM6152
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/10/2026
• 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
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 3 KG