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

Catalog Number	B3300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microclave® neutral connector had a leak issue.It was stated that they have received multiple reports of item b3300 leaking and/or cracking while being used.The customer reported that the event occurred on multiple, unspecified dates, starting 21-nov-2024.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
Two (2) used list #b3300, clave¿ neutral connector were returned for evaluation on 12/13/2024.One of them came connected with 0.9% sodium chloride injection, usp sterile solution single use 10 ml bd syringe.As received, blood residual was found inside sample #1.The syringe was disconnected from sample #2 and a stick down was observed.Both claves were leak tested and no internal/external leaks were observed, when they were dissembled on sample #2 a residual fluid stuck on the spike and an acceptable flash on the perimeter of the seal face was found.No additional damage was observed.The id of the returned syringe (mating device) was measured finding within specification.Complaint of leaks can be confirmed based on the internal blood residual found on sample #1.The probable cause is unknown.Lot history review was performed and no discrepancies, anomalies or nonconformances were identified that might lead the condition reported by the customer.

• Brand Name: MICROCLAVE® 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: 21035457
• Report Number: 9617594-2024-01884
• Device Sequence Number: 20740943
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)290201(10)13909700
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100434
• 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): 03/25/2025

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: B3300
• Device Lot Number: 13909700
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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