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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a clave¿ neutral connector where the customer reported that some units, not all from the same box, developed cracks when connected to the syringe.No medications were administered during the use of the products, and the products were neither reprocessed nor re-sterilized prior to use.The event occurred during patient use, when the syringe was inserted in the connector; there was no harm reported as a consequence of this event.
Additional Manufacturer Narrative
The customer returned a couple of photos for evaluation which showed a crack on the blue body, when a syringe is connected, the item and lot information were shown.No additional damage or anomalies are observed.Two (2) used.List #011-c3300, clave¿ neutral connector and two (2) new.List #unknown, 5ml and 2ml syringes were returned for evaluation.As received an unknown residual, a visible crack and crazing marks around the claves were confirmed.The returned claves were tested as procedure and no leak was confirmed.The male luer taper of the returned syringes met the product specification.Complaints of cracks can be confirmed.The probable cause is due to environmental stress during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21677987
• Report Number: 9617594-2025-00541
• Device Sequence Number: 8311491
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)271001(10)10986033
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2025

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: 10986033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2 BRAUN OMNIFIXSYRINGES
• Patient Sex: Unknown