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

Catalog Number	12662-28
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum administration set, and it was reported that there were black spots or defects with the tubing.There were no reported patient involvement and no reported patient harm.
Additional Manufacturer Narrative
The device is not available for investigation however a photo review should be performed, and a supplemental report will be submitted.D4: only di provided as lot number is unknown.(b)(6).

• Brand Name: LIFESHIELD¿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 ; CA
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25356983
• Report Number: 9615050-2026-00330
• Device Sequence Number: 10612990
• Product Code: FPA
• UDI-Device Identifier: 10887787005643
• UDI-Public: (01)10887787005643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/30/2026

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/30/2026
• 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