MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP EXT 8IN MACROB 1Y-CLV-SL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	206540451
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an extension set, 8 inch, clave(tm) y-site, secure lock and it was reported that there was a possible leak in the product.There had been multiple incidences of saline spraying out of them, and this continued even after double-checking all the connections.There was 2 minutes delayed in therapy.The patient was fine.The concern was directed to the nurse who administered the medication, particularly the chemotherapy medication.There was patient involvement, and no harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Additional contact information: (b)(6).

• Brand Name: NDEHP EXT 8IN MACROB 1Y-CLV-SL
• 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: 24797550
• Report Number: 9615050-2026-00219
• Device Sequence Number: 9538087
• Product Code: FPA
• UDI-Device Identifier: 10887787005858
• UDI-Public: (01)10887787005858(17)280401(10)14392104
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 206540451
• Device Lot Number: 14392104
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: SALINE SOLUTION, UNK MFR; UNSPECIFIED CHEMOTHERAPY MEDICATION, UNK MFR
• Patient Sex: Unknown