MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 32 INCH, 2 PREPIERCED Y-SITES, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126480451
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an extension set, 32 inch, 2 prepierced y-sites, secure lock where the customer reported that 'any pulling at all' causes the extension set to come apart at the y site.The event date was 23-jun-2025.There was unknown patient involvement and no adverse event/patient injury reported.
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation; a device history review will be conducted.
Additional Manufacturer Narrative
Investigation summary: 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, 32 INCH, 2 PREPIERCED Y-SITES, 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: 22667843
• Report Number: 9615050-2025-00363
• Device Sequence Number: 3825237
• Product Code: FPA
• UDI-Device Identifier: 10887787005469
• UDI-Public: (01)10887787005469(17)270901(10)14076852
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 126480451
• Device Lot Number: 14076852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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