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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a clave¿ neutral connector where it was reported there was a broken needleless connector which was found during continuous infusion.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
A photo was shared by customer, where a broken piece of the microclave is observed to be stuck on the male luer's mating device, no additional damage or anomalies are observed.One used list# 011-c3300, microclave® connector, connected to an unknown, infusion set were returned for evaluation.As received the microclave was observed to be broken off, beach marks and crazing inside the clave was confirmed.No additional damage or anomalies were confirmed.Complaints of cracks can be confirmed.The probable cause was due the probable cause is due to environmental stress during use.The lot history was reviewed, 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: 22090015
• Report Number: 9617594-2025-01097
• Device Sequence Number: 6906742
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)290901(10)14146553
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 06/26/2025

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: 14146553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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