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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporter (b)(6).The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
Event occurred regarding a clave neutral connector where they reported that, "they connected c3300 on 3-way which put on a-line.After they drew off blood with syringe, the blood stay between the silicone and the housing.They couldn¿t flush clear with normal saline.There was no bleed back, no biohazard, no chemo." they reported that five (5) quantity was affected.There was patient involvement, but no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
The complaint could not be confirmed by the investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review (dhr) was reviewed, and no nonconformities were found that would have led 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: 22861730
• Report Number: 9617594-2025-01724
• Device Sequence Number: 15792505
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2024
• 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