MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH; 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	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date and involved the following medical device: primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch.Leakage of an unspecified fluid/infusate was reported at different places on the 1.2 micron filter, once along the side of the filter once in the back where the little holes of the filter are.Patients are usually the ones noticing the leak within ten minutes of starting the infusion with new tubing.The customer reported that these leaks require the system to be changed more often than necessary.There was no report of any human harm.This emdr reflects nine occurrences of the same failure mode with no other unique information provided to differentiate any of the events individually.

• Brand Name: PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25027917
• Report Number: 9615050-2026-00261
• Device Sequence Number: 10126905
• Product Code: FPA
• UDI-Device Identifier: 10887787005407
• UDI-Public: (01)10887787005407(17)281101(10)14576672
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: 125390490
• Device Lot Number: 14576672
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2025
• 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