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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used stopcock; lot #unknown, connected to an used 3 ml syringe and one used.List #011-c3300, clave¿ neutral connector and additional one (1) used.List #011-c3300, clave¿ neutral connector were returned for evaluation.As received no damage or anomalies were observed.The samples were tested as procedure and no leaks were confirmed, the claves were dissembled and a partial coring in on of the sample was confirmed.The returned syringe was measured finding within specification.The samples were tested as returned, leak was unable to be replicated or confirmed tested under laboratory test and procedure.Once the sample was dissembled a partial coring on the seal was observed.Therefore this condition might be leading a leaks, even the returned syringe was within specification.The probable is typical due to access with an incompatible mating device during use.The probable cause is typical due to incompatible mating device during use, direction for use (dfu) states: the clave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a clave¿ neutral connector where it was reported that during iv push administration, leakage was observed from the blue connector.There was patient involvement but no patient harm.There was no delay in critical therapy.

• 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: 23293944
• Report Number: 9617594-2025-01985
• Device Sequence Number: 20029638
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)291001(10)14169020
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 14169020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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