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 Codes	Break (1069); Material Separation (1562)
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
E1 customer extension number- (b)(6).The device has been received for evaluation; however, investigation has not been completed.Additional contact information distributor: (b)(6).
Event or Problem Description
The event involved an 11" ext set w/6-port nanoclave¿ manifold, check valve, nanoclave¿, clamp, luer lock where the customer reported that the product broke and disengaged, and that the iv fluid and medication were no longer infusing into the patient.This was noted during patient assessment.There was patient involvement, and no patient injury reported as a consequence to this event.
Additional Manufacturer Narrative
Investigation summary: one (1) photo was shared by customer, showing the body separated from the nanoclave and the seal is shown.No additional damage or anomalies are observed.One (1) used.List #am6143, 11" connected to an unknown, primary plum set; lot #unknown.As received, the nano clave was observed to be separated from the manifold, additional the nano clave's body was connected into the returned female luer's mating device.The subassembly clave nano was visually inspected, and a crush spike was observed, seal and boy were not returned for evaluation.Some scratches/marks were visually observed on the spike clave nano were the body fits.The id of the returned male luer was measured finding within specification.Complaint of product broke and disengaged can be confirmed.The probable cause is unknown.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: 22135176
• Report Number: 9617594-2025-01143
• Device Sequence Number: 8391592
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• 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: 06/03/2025
• 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 IV MEDICATION, MFR UNK
• Patient Sex: Unknown