MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126600490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, however, device history review should be conducted.
Event or Problem Description
The event gcm received a call on (b)(6) 2025 from mrs.(b)(6) of (b)(6) hospital with regard to extension set, 7 inch, clave connector, secure lock with item number (b)(4) and lot number 14034924.The reporter stated, "our director of pharmacy was doing some iv and she's having an issue with the extension set 7" and she said that it leak when you put it in the iv site no matter how tight you put it".The medication infusing at the time of the event was unknown.Sample product was discarded.There was patient involvement, unknown adverse event and unknown delay in therapy.Lpalma (b)(6) 2025.
Additional Manufacturer Narrative
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, 7 INCH, CLAVE CONNECTOR, 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: 22956207
• Report Number: 9615050-2025-00418
• Device Sequence Number: 18243885
• Product Code: FPA
• UDI-Device Identifier: 10887787005612
• UDI-Public: (01)10887787005612(17)270801(10)14034924
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 126600490
• Device Lot Number: 14034924
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2024
• 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