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	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding extension set, 7 inch, clave connector, secure lock where it was reported that they had two instances where the tubing was leaking/dripping.When the device was flushed, it was connecting the tubing to the iv insight then it began to leak.The tubing that connects to the blue hub is where it leaked in all instances.There was reported patient involvement and no patient harm.
Additional Manufacturer Narrative
Additional reporter: (b)(6).The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Updated information in d8 and d9.

• 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: 23442396
• Report Number: 9615050-2025-00515
• Device Sequence Number: 8625619
• Product Code: FPA
• UDI-Device Identifier: 10887787005612
• UDI-Public: (01)10887787005612(17)270201(10)13873722
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 13873722
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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