MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	206680490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an extension set, 17inch, 0.2 micron filter, clave (tm), y-site, secure lock and it was reported that the device has a leaking issue during infusion of mixed chemotherapy (doxorubicin, etoposide and vincristine).There was patient involvement, no harm and did cause a delay in therapy.This report captures second of four incidents.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
H10 - additional related report numbers.9615050-2025-00625-00.9615050-2025-00624-00.Sixteen new extension sets were received for evaluation on 12/29/2025.As received, no damage or anomalies were noted.One photo was received for review also and it showed a set with leakage at the inline filter.The filter on the sixteen new sets were leak tested and no leakage was observed on any of them.The reported complaint of leakage at the filter cannot be replicated but can be confirmed for one set based on the customer provided photo.The probable cause cannot be determined without the return of the reported set.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EXTENSION SET, 17 INCH, 0.2 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: 23835518
• Report Number: 9615050-2025-00622
• Device Sequence Number: 17416702
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)280501(10)14338083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 206680490
• Device Lot Number: 14338083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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: DOXORUBICIN, UNK MFR.; ETOPOSIDE, UNK MFR.; VINCRISTINE, UNK MFR.
• Patient Sex: Unknown