MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	11956
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.
Event or Problem Description
On an unspecified date, a clave¿ connector reportedly was associated with particulate matter in final drug product across multiple lots.The final drug product contained particulates such as cellulose/lignin, cellulose fiber, polypropylene, polyethylene, pvdf-hfp, textile cotton fiber, textile polyester fiber, eva, indigo cellulose or cotton fiber and fluorocarbon-based material.There was no reported patient involvement and no reported patient harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review was conducted, and no nonconformities were found that would have led to the reported complaint.The complaint of particulate matter cannot be confirmed.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23752356
• Report Number: 9617594-2025-02268
• Device Sequence Number: 9365701
• Product Code: FPA
• UDI-Device Identifier: 00887709042193
• UDI-Public: (01)00887709042193(17)280501(10)13625254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/06/2026

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: 11956
• Device Lot Number: 13625254
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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