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	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 lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Evaluation of the returned sets confirmed the presence of black spots and white discoloration adhered to the interior wall of the drip chamber.Measurement of the black spots identified zero (0) sets as out of specification.Measurement of the white discoloration identified one (1) set as out of specification.Measurement of both black spots and white discoloration identified one (1) set as out of specification.The adhered spots observed during evaluation were confirmed to be embedded within the drip chamber.Icu medical has completed its investigation and determined that these represent discolored material originating during the molding process and embedded within the drip chamber wall.These findings are not consistent with foreign or biological contamination, and testing demonstrates that the material does not dislodge or migrate.Functional flushing of the set resulted in no loose residual particles.The reported complaint of black spots can be confirmed.The cause of the black spots in the drip chamber is due to discoloration of the pvc material during the molding process.The cause of the white discoloration inside the drip chamber is due to errant solvent applied during the assembly process in costa rica.
Event or Problem Description
The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 128 inch that the contamination 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, and the biological nature of the particulates remains unknown.The event occurred prior to patient use and upon inspection of the product.There were no patient involvement and no patient harm.

• 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: 25553017
• Report Number: 9615050-2026-00566
• Device Sequence Number: 10751641
• Product Code: FPA
• UDI-Device Identifier: 00887709102460
• UDI-Public: (01)00887709102460(17)280601(10)14371974
• 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): 06/18/2026

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: 14371974
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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