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

Catalog Number	11956
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A lot number has been provided.A device history lot review is pending.
Event or Problem Description
The event occurred on an unspecified date and involved a clave¿ connector where it was reported that port connectors were leaking.There was unknown patient involvement and no injuries or adverse event.
Additional Manufacturer Narrative
No 11956 product samples, videos or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.Lot history review was conducted, and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: CLAVE¿ 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: 21976126
• Report Number: 9617594-2025-00924
• Device Sequence Number: 7265592
• Product Code: FPA
• UDI-Device Identifier: 00887709042193
• UDI-Public: (01)00887709042193(17)291001(10)14168608
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 11956
• Device Lot Number: 14168608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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