MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. APPX 1.1 ML, 4 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	AC401
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a appx 1.1 ml, 4 gang 4-way nanoclave® stopcock w/baseplate, rotating luer.The report stated that the registered nurse used hemostats on the manifold and a nanoclave port broke off.There was patient involvement and there was no harm/adverse event reported.The product fault occurs while in use with a patient- after infusion.
Additional Manufacturer Narrative
Received one (1) used list# ac401, 4 gang 4-way nanoclave® stopcock w/baseplate attached to an unknown clave.As received the clear nano body subassembly was detached from the stopcock.The nano clave body had cold form damage on the body typical of tool use.Both bond sites appeared to have adhesive residue.The complaint of nanoclave port breaking off can be confirmed.The probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: APPX 1.1 ML, 4 GANG 4-WAY NANOCLAVE® STOPCOCK W/BASEPLATE, ROTATING 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: 20072772
• Report Number: 9617594-2024-01203
• Device Sequence Number: 3035393
• Product Code: FMG
• UDI-Device Identifier: 00887709090354
• UDI-Public: (01)00887709090354(17)290501(10)13997898
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• 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
• Report Date (Section B): 08/26/2024

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: AC401
• Device Lot Number: 13997898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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
• Patient Sex: Unknown