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	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event occurred on an unspecified date involved a secondary set, secure lock, 34 inch where it was reported that the product appeared to have black spots.There was no patient involvement or harm associated with the event.
Additional Manufacturer Narrative
Received one opened/unused secondary set for inspection.Visual inspection and functional testing was carried out.As received, no damage or anomalies noted.The returned set was connected to an icu medical provided iv bag with sterile water.The fluid from the bag was flushed through the set and collected in a vacuum filtration system.The filter paper was examined under a microscope at 10x magnification to check for particulates from the set.There were no residual particles on the filter paper.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.

• 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: 25425574
• Report Number: 9615050-2026-00398
• Device Sequence Number: 9929418
• Product Code: FPA
• UDI-Device Identifier: 10887787006282
• UDI-Public: (01)10887787006282(17)290201(10)14860292
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 14860292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2026
• 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