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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received one used.List #206680490, extension set.As received, the inlet and outlet on the filter were wetted out.Received one photo of the packaging.The filter was leak tested.Leakage was observed at the inlet and outlet.The reported complaint of leakage at the filter can be confirmed.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter material due to an infusate interaction during use.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.B3 date of event: december 1, 2025, used as a place holder due to unknown date of event.
Event or Problem Description
The event involved an extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock where it was reported a baby with a peripherally inserted central catheter (picc) line had leaking intravenous fluid (ivf) from the iv filter.When the device was switched out a crack was noticed in the filter.There was patient involvement and no patient harm reported.
Event or Problem Description
An email was received regarding an extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock, stating that they had a baby this week with a peripherally inserted central catheter (picc) line, and the nurses noticed leaking in vitro fertilization (ivf) from the intravenous (iv) filter.When they switched it out, they noticed a crack in the filter.Total parenteral nutrition (tpn) is being infused at 2.5 ml/hr.The cracked filter resulted in iv fluid leaking, and ultimately the picc line clotted and had to be removed and a new one was placed the following day.A sample photo was provided showing the product inside the packaging.There was patient involvement and no patient harm.

• 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 ; .; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24070041
• Report Number: 9615050-2026-00013
• Device Sequence Number: 13332606
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)280801(10)14512290
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 206680490
• Device Lot Number: 14512290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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: IV FLUID, UNK MFR.; PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown