MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	125390490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 in reportedly leaked an unspecified fluid at the filter a few hours after administration on multiple different incidents and different floors.There was no human harm.This emdr reflects one of two similar occurrences.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The complaint investigation is pending at this time.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint cannot be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 IN
• 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: 23405551
• Report Number: 9615050-2025-00494
• Device Sequence Number: 11993851
• Product Code: FPA
• UDI-Device Identifier: 10887787005407
• UDI-Public: (01)10887787005407(17)280401(10)14299920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 Expiration Date: 04/20/2025
• Device Catalogue Number: 125390490
• Device Lot Number: 14299920
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID/INFUSATE, MFR UNK.
• Patient Sex: Unknown