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 Codes	Crack (1135); 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
Additional Manufacturer Narrative
E1 - additional contact telephone number (b)(6).
Event or Problem Description
The event occurred on unspecified date(s) and involved microclave® neutral connector.The customer reported that the device was leaking and/or cracking while being used.The event occurred multiple days from 21-nov-2024.There was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One (1) used list #b3300, clave¿ neutral connector was returned for evaluation on 12/13/2024.As received, blood residual inside the sample was observed.No significant damage or anomalies were observed.The returned set was tested and no internal/external leaks were observed, the set was dissembled and no anomalies were observed.Complaint of leaks can be confirmed based on the internal blood residual.The probable cause is unknown.However, without the return of used mating device for investigation a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.Lot history review was performed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21044648
• Report Number: 9617594-2024-01898
• Device Sequence Number: 15555871
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)290501(10)13998105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: 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: 13998105
• 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: 05/01/2024
• 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