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	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved an extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock where the customer reported concerns of the device leaking when administering hazardous aerosolizing medications.Immediate solution: 5a will use 120493 - tubing iv set plum w/.22 micron h/p filter to align with behring practice for hazardous medications requiring a filter.There was patient involvement, but harm was not reported as a consequence of the event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
D9 - device available for evaluation: no.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: 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24873981
• Report Number: 9615050-2026-00231
• Device Sequence Number: 18373073
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)280701(10)14445250
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 14445250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: TUBING IV SET PLUM W/.22 MICRON H/P FILTER, ICU.
• Patient Sex: Unknown