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	02/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date; the 1st day of the month reported has been used as a placeholder.The event involved a primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch, which was reported to be leaking at the white port on the lipid tubing that goes to the pump as it is vented.Patient involvement was not reported; but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01-feb-2026 has been used as a placeholder.D4 - primary udi number - the primary di# has been used as the lot information is unknown.It is unknown if the device is available for evaluation.The device has been requested to be returned; however, it has not been received.Without the returned device, a probable cause is unable to be determined.A lot number was not provided.A device history lot number review cannot be performed.
Event or Problem Description
The event occurred on an unspecified date; the 1st day of the month reported has been used as a placeholder.The event involved a primary plum set, 1.2 micron filter, clave y-site, secure lock, 104 inch, which was reported to be leaking at the white port on the lipid tubing that goes to the pump as it is vented during infusion.There was patient involvement; but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The following fields were updated with additional information/correction due to information received form the customer: b3 - date of event.B5 - describe event or problem.D4 - lot #, expiration date, primary udi number.H4 - device manufacture date.

• 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 ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24606761
• Report Number: 9615050-2026-00190
• Device Sequence Number: 10402605
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 07/29/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/02/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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
• Patient Sex: Unknown