MAUDE Adverse Event Report: ICU Medical Costa Rica Ltd. Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch; Set, administration, intravascular

Catalog Number	14687-28
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.It was reported that there seemed to be a hair or eyelash floating in the solution, which was supposed to be sterile.It occurred upon drawing up saline into the drip chamber, the floating feather like thing floated within the chamber (not present within the saline).There was patient involvement (but the nurse saw the feather and reported the fault before the patient was affected) and no harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1 - (b)(6).

• Brand Name: Primary PLUM Set, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch
• Common Device Name: Set, administration, intravascular
• Manufacturer (Section D): ICU Medical Costa Rica Ltd.; zona franca global; la aurora heredia NA ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50729546
• Report Number: 9615050-2026-01180
• Device Sequence Number: 10662302
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 09/11/2026

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: 14687-28
• Device Lot Number: 290301
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/11/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown