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 is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.B3 - date of event: since the exact event date was unknown, it was updated as first day of the month of awareness.(b)(6).
Event or Problem Description
The event involved a primary set, piggyback with backcheck valve, 2 clave y-sites, secure lock, 100 inch, and it was reported there was small black dots on the internal walls of the drip chambers.There were 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: 25406628
• Report Number: 9615050-2026-00361
• Device Sequence Number: 21511930
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643(17)290101(10)14822772
• 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: Consumer
• 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: 14822772
• 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: 01/08/2026
• 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