MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	011-AM3090
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).One used device was returned for evaluation.As received, one of the nanoclaves was missing and was not returned for evaluation.Enough presence of adhesive at the manifold base with uv light was confirmed.The 2 remaining nanoclaves on the used sample were torque tested, and both met the product specifications.Complaint of separation can be confirmed but the probable cause is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a 25 cm (10") ext set w/3-port nanoclave® manifold, check valve, clamp, luer lock where the customer reported that when the nurse entered the room, he noticed that the infusion line that should be connected to the manifold was on the floor, as its medial port was detached from the base.The product was in sue for one day, it had not been reprocessed or re-sterilized prior to use.Paracetamol was being used with the device; the event occurred during patient use and there was delay in therapy but there was no patient harm as a result of this event.

• Brand Name: 25 CM (10") EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK
• 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: 22976817
• Report Number: 9617594-2025-01796
• Device Sequence Number: 21062379
• Product Code: FMG
• UDI-Device Identifier: 00840619091729
• UDI-Public: (01)00840619091729(17)190101(10)13891479
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: 011-AM3090
• Device Lot Number: 13891479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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: PARACETAMOL, MFR UNK
• Patient Sex: Unknown