MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET 34 INCH WITH IV SET HANGER, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	SF3258-15H-04
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint cannot be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a secondary set 34 inch with iv set hanger, secure lock.It was reported that the secondary line for zometa which is a class r medication running as a secondary, started leaking.This is a major safety issue potentially exposing team member and patient to medication.The status of the product at the time of event was when the device was opened and connected to medication.No patient harm.

• Brand Name: SECONDARY SET 34 INCH WITH IV SET HANGER, SECURE LOCK
• 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: 23285756
• Report Number: 9615050-2025-00471
• Device Sequence Number: 8762019
• Product Code: FPA
• UDI-Device Identifier: 10887709120201
• UDI-Public: (01)10887709120201(17)280501(10)14371935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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: SF3258-15H-04
• Device Lot Number: 14371935
• 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: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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: ZOMETA, MFR UNK.
• Patient Sex: Unknown