MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, SECURE LOCK, 34 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142290490
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation; however, a picture was provided.Investigation is pending.
Event or Problem Description
The event involved a secondary set, secure lock, 34 inch.It was reported as small black dots on the internal walls of the drip chambers and has been reported in numerous lots across three product types from icu medical.In some products, particulate matter appears in the lumen or chamber of the tubing.The particulate matter appeared to be embedded in the plastic material but not within the lumen or chamber.No adverse events have been linked to the products as it was noticed prior to patient use and upon inspection of the products, and the biological nature of the particulates remains unknown.The reported model and catalog number was 1422928 and in addition to the black speck, it was also noted that there were some white contaminants present in the product.Sample images provided by the reporter is available in the attachments.

• Brand Name: SECONDARY SET, SECURE LOCK, 34 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25509013
• Report Number: 9615050-2026-00519
• Device Sequence Number: 10552731
• Product Code: FPA
• UDI-Device Identifier: 10887787006282
• UDI-Public: (01)10887787006282(17)280901(10)14524260
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: 142290490
• Device Lot Number: 14524260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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