MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11" (28 CM) SMALLBORE EXT SET W/NANOCLAVE¿, 6-PORT NANOCLAVE¿ MANIFOLD, CHECK V; STOPCOCK, I.V. SET

Catalog Number	AM6127
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 11" (28 cm) smallbore ext set w/nanoclave¿, 6-port nanoclave¿ manifold, check valve, clamp, rotating luer where the customer reported that the registered nurse (rn) noticed that the manifold connected to the patient was leaking.The rn then reordered all new drips and replaced the manifold and the ggt lines connected to it.The manifold was leaking at the last port on the back where there was no bonded microclave, and the carrier solution was infusing through this port.The patient weighed 2.6kg.The medication infusing was sodium chloride 0.45% with heparin 1 unit/ml, rate 2ml/hr and the medication is infused by central line, the event occurred during patient infusion, but no harm was reported as a consequence of this event.
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.
Additional Manufacturer Narrative
Corrected/additional information - the device is not available, and lot number unknown, therefore the h6 codes have been updated.

• Brand Name: 11" (28 CM) SMALLBORE EXT SET W/NANOCLAVE¿, 6-PORT NANOCLAVE¿ MANIFOLD, CHECK V
• 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: 24970049
• Report Number: 9617594-2026-00401
• Device Sequence Number: 21446607
• Product Code: FMG
• UDI-Device Identifier: 00887709086357
• UDI-Public: 00887709086357
• 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,Followup
• Report Date (Section B): 04/29/2026

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: AM6127
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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: SODIUM CHLORIDE 0.45% W/HEPARIN 1 UNIT/ML, MFR UNK.
• Patient Age: 13 DA
• Patient Sex: Female
• Patient Race: White