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	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch reported that the customer had noticed over the past week involving the primary plum set 1.2 micron filter clave y.Several sets had been found leaking from the filter site during use.They had identified leaks in tubing used for three different patients.The event occurred during use.There was patient involvement and no reported harm.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.

• 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 NA ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50818528
• Report Number: 9615050-2026-01342
• Device Sequence Number: 10677657
• Product Code: FPA
• UDI-Device Identifier: 10887787005407
• UDI-Public: (01)10887787005407(17)290501(10)14928099
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 14928099
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2026
• 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