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

Catalog Number	AM6143
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Initial reporter full phone number: (b)(6).
Event or Problem Description
The complaint involved a 11" ext set w/6-port nanoclave¿ manifold, check valve, nanoclave¿, clamp, luer lock.While during inspection, the reporter stated that they found it was disconnected from the primary line and the patient's medications were running through the manifold.There was patient involvement and no patient injury.
Additional Manufacturer Narrative
Investigation summary: one (1) photo was shared by customer, showing the body from the nanoclave separated and the seal is shown.No additional damage or anomalies are observed.One (1) used.List #am6143 was returned for evaluation.As received the subassembly clave nano body was separated showing the seal and the spike, the spike is crushed, the body was not returned.No additional damage or anomalies were noted.Complaint of separation can be confirmed.The probable cause cannot be determined.The lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 11" EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK VALVE, NANOCLAVE¿, CLAMP, LUER
• 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: 22142237
• Report Number: 9617594-2025-01147
• Device Sequence Number: 8215626
• Product Code: FMG
• UDI-Device Identifier: 00887709098930
• UDI-Public: 00887709098930
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: AM6143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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: UNSPECIFIED MEDICATIONS, MFR UNK.; UNSPECIFIED PRIMARY LINE, MFR UNK.
• Patient Sex: Unknown