MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE¿ Y-SITES, 100 INC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12662-28
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint cannot be replicated or confirmed.The lot history could not be reviewed due to no lot number was provided.
Event or Problem Description
A reported incident involving a primary set, piggyback with backcheck valve, 2 clave y-sites, secure lock, 100 inch have black dots noted in hundreds of icu medical iv tubing.There were no reported patient involvement and harm.

• Brand Name: PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE¿ Y-SITES, 100 INC
• 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: 25659416
• Report Number: 9615050-2026-00658
• Device Sequence Number: 13363842
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 12662-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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