MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Clave¿ Connector; Set, Administration, Intravascular

Catalog Number	011-C1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved clave connector.It was reported patient's mom advised once they had connected the bionector was leaking so they had to change it and use another bag.The status of the product at the time of the event when it was connected to the patient.Unknown, leak observed after patient connected.The event occurred on (b)(6) 2026.The product in clinical use at the time of event.There was patient involvement.No patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1.Initial reporter phone is (b)(6).

• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50807925
• Report Number: 9617594-2026-01296
• Device Sequence Number: 8597145
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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
• Report Date (Section B): 09/17/2026

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-C1000
• Device Lot Number: 10986029
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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