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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inch where is was stated in the report that "the product would drip leucovorin from the filter vent during infusion." there was patient involvement but no patient harm.There was one (1) device quantity affected.
Additional Manufacturer Narrative
Additional reporter: (b)(6).The device has been requested for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
One used device was received for evaluation.As received, the filter was wetted out.The set was leak tested per specifications and no leakage was observed.The complaint of a leakage from filter vent 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.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Additional information d9 section.

• 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: 23021617
• Report Number: 9615050-2025-00427
• Device Sequence Number: 13148290
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)280101(10)14205091
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 123390488
• Device Lot Number: 14205091
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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: LEUCOVORIN, MFR UNKNOWN
• Patient Sex: Unknown