MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-C3300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unknown date involving a clave¿ neutral connector reportedly leaked at the connector, despite all external connections being securely in place.This leakage resulted in a sudden drop in blood sugar level of the patient.Upon further investigation, they discovered that the issue originated from the valve connector itself.Notably, the defect was not immediately visible and only became apparent when the connector was flushed independently, without being attached to the other components.There was no report of any human harm.
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it is not available for investigation at this time.A review of the device history record is pending.The investigation is pending.
Additional Manufacturer Narrative
D9 - date returned to mfg is 8/14/2025.Received one (1) used list# 011-c3300, microclave® connector; lot# 14080316.One (1) used list# unknown, 3ml syringe; lot# unknown.When disconnected from the syringe, a torn seal was observed.The reported complaint of a leak could be confirmed.The returned sample was observed to have a torn seal which would lead to a leak.The probable cause of the torn seal is from an unintentional needle strike during use.The lot history was reviewed.No nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CLAVE¿ NEUTRAL CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 22332474
• Report Number: 9617594-2025-01345
• Device Sequence Number: 20939977
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)290701(10)14080316
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970855
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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-C3300
• Device Lot Number: 14080316
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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