MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	146870489
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch where it was reported that there was a black speck located in/on the drip chamber of iv (intra- venous) tubing upon removal from the package.There was no patient involvement, and no patient harm reported.Seven unused primary plum sets were returned for investigation, out of which six were found to have black specks present in the drip chamber.This report captures the second of 6 affected samples returned.
Additional Manufacturer Narrative
Received seven opened/unused primary plum sets for inspection.The sets were examined under uv light.Six had black specks, zero had solvent smears, and zero had both.Received five photos of black specks in the drip chamber.Evaluation of the returned sets confirmed the presence of black spots adhered to the interior wall of the drip chamber.Measurement of the black spots identified zero sets as out of specification.The adhered spots observed during evaluation were confirmed to be embedded within the drip chamber.Upon investigation completion 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 in the drip chamber 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 lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Distributor details: medline.

• Brand Name: NDEHP PLUMSET 2CLAVES-SL
• 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: 25518933
• Report Number: 9615050-2026-00538
• Device Sequence Number: 9940161
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)281201(10)14800330
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Distributor
• Initial Reporter Occupation: Nurse
• 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: 146870489
• Device Lot Number: 14800330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• 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: 12/09/2025
• 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