MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 29" EXT SET W/NANOCLAVE® 4-WAY STOPCOCK, CLAMP, ROTATING LUER, 1 EXT; STOPCOCK, I.V. SET

Catalog Number	AC215
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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 29" ext set w/nanoclave 4-way stopcock, clamp, spin luer, 1 ext that experienced disconnection and leakage.The reporter stated that while patient was rinsing before chemo began, the primary tubing/extension tubing disconnected and iv fluids were leaked to the floor from iv pump, and blood mixed with fluid from patient's port was also leaked to patient chair and floor.There was patient involvement, there was delay in therapy and no adverse event, but the chemo was spilled and leaked.
Additional Manufacturer Narrative
No ac215 product samples, videos or photographs were returned for investigation.The complaint cannot be confirmed, without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Lot history review was unable to conducted as no lot number information was provided.

• Brand Name: 29" EXT SET W/NANOCLAVE® 4-WAY STOPCOCK, CLAMP, ROTATING LUER, 1 EXT
• 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: 21953092
• Report Number: 9617594-2025-00884
• Device Sequence Number: 8691834
• Product Code: FMG
• UDI-Device Identifier: 00840619082536
• UDI-Public: 00840619082536
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: AC215
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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
• Patient Sex: Unknown