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

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
Event or Problem Description
The event involved a primary set, piggyback with backcheck valve, 2 clave y-sites, secure lock, 100 inch: it was reported that black spec isn¿t always imbedded into the material in the chamber.The black spec was easily wiped away with a finger, so this is not embedded into the material.They were able to wipe it off after cutting the chamber open.If they see a black spec, it is coming back as a return.When their team found the product and cut it open 2 of them were easily wiped off.There were no reported patient involvement and harm.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.The device is available for evaluation; however, has not been received.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 I
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET.
• 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: 25485812
• Report Number: 9615050-2026-00473
• Device Sequence Number: 10513347
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643(17)281201(10)14802329
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: 14802329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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