MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	123390488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An incident involving a primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inch reported that leakage was noted at filter vent after 0.2 hours of infusion.Vent cap was closed.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.(b)(6).
Additional Manufacturer Narrative
Product received date - 1/14/2026.One used device was returned for investigation.During visual inspection, found that the filter was wetted out.Received one (1) photo of the set in a bag.The set was leak tested per specifications and no leakage was observed.The complaint of a leakage cannot be replicated but can be confirmed due to the wetted-out filter.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.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE
• 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: 23824956
• Report Number: 9615050-2025-00615
• Device Sequence Number: 5067591
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)280501(10)14338114
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• 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): 02/28/2026

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: 123390488
• Device Lot Number: 14338114
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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: PEXEDA 20ML IN 100ML NACL (FLOW RATE: 665ML/HR).
• Patient Sex: Unknown