MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15687-28
Medical Device Problem Code	Contamination (1120)
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
Twenty-one new, unused samples were returned for evaluation.The sets were examined under uv light, and fourteen sets were found to contain black specks.The sets were flushed with sterile water, and the drip chamber was isolated and primed by squeezing it six times, followed by flushing 100 ml of sterile water through the set.The effluent was collected using a vacuum filtration system and passed through filter paper, which was then examined under a microscope at 10× magnification.No residual particles were observed.The complaint of black spots in the drip chamber was confirmed, and the cause was determined to be discoloration of the pvc material during the molding process.Lot history was reviewed and no anomalies were noted.(b)(6).
Event or Problem Description
Twenty-one new, unused primary plum sets were returned for investigation, of which fourteen were found to have black specks present in the drip chamber.The particulate matter appeared to be embedded in the plastic material and not within the lumen or chamber.There was no patient involvement and no harm or adverse event reported.This report captures seven of fourteen devices returned.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 128 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: 25516946
• Report Number: 9615050-2026-00527
• Device Sequence Number: 9993913
• Product Code: FPA
• UDI-Device Identifier: 00887709102460
• UDI-Public: (01)00887709102460(17)290101(10)14843690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• 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
• Report Date (Section B): 06/16/2026

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: 15687-28
• Device Lot Number: 14843690
• 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: 06/12/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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