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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device returned for evaluation.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.The reported complaint of particulate matter cannot be replicated or confirmed as evaluation of the returned set did not confirm the presence of black specks.
Event or Problem Description
An event occurred on an unspecified date involving the product secondary set, secure lock, 34 inch reporting that there were black specks in the drip chambers.There was no reported patient involvement or harm.

• 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: 25572325
• Report Number: 9615050-2026-00622
• Device Sequence Number: 17446643
• Product Code: FPA
• UDI-Device Identifier: 10887787006282
• UDI-Public: (01)10887787006282(17)281101(10)14623286
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2026

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: 14623286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• 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