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	Contamination (1120)
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
The device has been received for evaluation; however, investigation is not yet complete.
Event or Problem Description
The event occurred on an unspecified date involving a primary set, piggyback with backcheck valve, 2 clave y-sites, secure lock, 100 inch, and it was reported that there is some black spots and debris found in the drip chamber.There was no reported 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: 25441011
• Report Number: 9615050-2026-00424
• Device Sequence Number: 10136796
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643(17)281101(10)14610290
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 14610290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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