MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	B91260490
Medical Device Problem Code	Fluid/Blood Leak (1250)
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
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date involving a primary set, 3 clave y-sites, 100 inch, non-deh, and it was reported that the anti-reflux valve is permeable, so not functional.The injected medication rises in the solution and is not properly administered to the patient.Inadequate dosage for the administration of medication, which can have harmful consequences for the patient.There were no reported patient involvement or harm.

• Brand Name: PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP
• 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: 25530948
• Report Number: 9615050-2026-00553
• Device Sequence Number: 9633931
• Product Code: FPA
• UDI-Device Identifier: 10887787009306
• UDI-Public: (01)10887787009306(17)281101(10)14571061
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142367
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: B91260490
• Device Lot Number: 14571061
• 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: 05/28/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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
• Patient Sex: Unknown