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

Catalog Number	126620490
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
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Lot history was reviewed and no anomalies were noted.(b)(6).
Event or Problem Description
The incident was reported by the massachusetts department of public health.The event involved a primary set, piggyback with backcheck valve, 2 clave y-sites, secure lock, 100 inch, where small black dots were observed on the internal walls of the drip chambers.There was no patient involvement and no reported patient harm.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 I
• 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: 25409507
• Report Number: 9615050-2026-00368
• Device Sequence Number: 10327115
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643(17)280601(10)14444800
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 126620490
• Device Lot Number: 14444800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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