MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14018-04
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned.The device evaluation will proceed with the available information with results sent in final report.D4: only di provided as lot number is plots.14614725 - mfr dt: 11/03/2025, exp dt: 11/01/2028 14800348 - mfr dt: 12/08/2025, exp dt: 12/01/2028 (b)(6).
Event or Problem Description
An event occurred on an unspecified event date involving a iv tubing set reported that there was a range of black and brown dots found inside the drip chamber and also found inside the area where the drip chamber was narrowed into the tubing as well as the smaller chamber just above the drip chamber.There was no patient involvement and no harm/adverse event reported.

• Brand Name: PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH
• 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: 25500231
• Report Number: 9615050-2026-00505
• Device Sequence Number: 10520021
• Product Code: FPA
• UDI-Device Identifier: 10887709101842
• UDI-Public: (01)10887709101842
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2026

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: 14018-04
• Device Lot Number: PLOTS
• 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: 05/24/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown