MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142560488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch in which it was reported that medication leaked from the filter vent when the vent cap was not opened during use.There was patient involvement, but no patient harm.
Additional Manufacturer Narrative
D9 - date returned to mfr: 3/5/2026 received one (1) used.List #unknown, sodium chloride inj.0.9% 250 ml intravenous bag with one (1) used.List #unknown, clave bag spike and one (1) used.List #unknown, spiros bag spike with one (1) used.List #142560488, primary plum set for inspection.As received, no damage or anomalies noted.The set was leak tested per specifications and no leakage was observed.The complaint of a leakage cannot be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT
• 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: 24299655
• Report Number: 9615050-2026-00069
• Device Sequence Number: 15786004
• Product Code: FPA
• UDI-Device Identifier: 10887787005230
• UDI-Public: (01)10887787005230(17)280401(10)14338116
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 142560488
• Device Lot Number: 14338116
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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: 5- FLUOROURACIL, MFR UNKNOWN.
• Patient Sex: Unknown