MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 15 INCH, 1.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	123540451
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Event or Problem Description
The event was reported via medsun uf/importer report # (b)(4) and involved an extension set, 15 inch, 1.2 micron filter, clave(tm) y-site, secure lock.The date of event was an unknown date in may 2025; 1st may 2025 has been used as a placeholder.The customer reported that a peripherally inserted central catheter (picc) line was disconnected, and it was found that the tubing was severed at the micron filter site.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Additional information is in the attachment section.

• Brand Name: EXTENSION SET, 15 INCH, 1.2 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 ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23619472
• Report Number: 9615050-2025-00556
• Device Sequence Number: 13024618
• Product Code: FPA
• UDI-Device Identifier: 10887787005339
• UDI-Public: 10887787005339
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 123540451
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 19 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White