MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, 34 INCH, NON-DEHP WITH INFUSION STAND HANGER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14230-28
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
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Event or Problem Description
The event occurred on an unspecified date involving a secondary set, 34 inch, non-dehp with infusion stand hanger, and it was reported that mobile and immobile debris floating in the drip chamber of the intravenous tubing after spiking a normal saline bag was found.The speck could not be removed from the plastic inner surface of the drip chamber even with aggressive scraping using a scalpel.There was no reported patient involvement, and no reported harm.

• Brand Name: SECONDARY SET, 34 INCH, NON-DEHP WITH INFUSION STAND HANGER
• 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: 25441044
• Report Number: 9615050-2026-00425
• Device Sequence Number: 21366530
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 14230-28
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/09/2026
• 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