MAUDE Adverse Event Report: ICU Medical Costa Rica Ltd. Extension Set, 17 Inch, 0.2 Micron Filter, CLAVE(TM) Y-Site, Secure Lock; Set, Administration, Intravascular

Catalog Number	206680490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involving a extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock.It was reported that an infant was receiving total parenteral nutrition (tpn) through iv tubing when leakage was observed from the filter.The filter was connected to the administration set infusing the tpn solution.Upon identification of the leak, the filter was removed and replaced using sterile technique, and the tpn infusion was resumed.No blood or body fluids were present in the line.The event occurred during infusion and no injury or adverse event was reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• Brand Name: Extension Set, 17 Inch, 0.2 Micron Filter, CLAVE(TM) Y-Site, Secure Lock
• 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: 50487078
• Report Number: 9615050-2026-00891
• Device Sequence Number: 15995858
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)290201(10)14885690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• 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: Non-Healthcare Professional
• Type of Report: Initial
• 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: 206680490
• Device Lot Number: 14885690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Total Parenteral Nutrition (Unk Mfg)
• Patient Sex: Unknown