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	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Unspecified iv fluid reportedly leaked out of the tubing of a secondary set 34 inch with iv set hanger, secure lock from the site where the hard connector connects with the flexible tubing.There was no report of any human harm.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint cannot be replicated or confirmed.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.Additional contact: (b)(6).
Additional Manufacturer Narrative
Investigation summary 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.
Additional Manufacturer Narrative
Additional information section a and b5, b6 and b7.
Event or Problem Description
Additional information received that there was no patient involvement in this event.

• 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: 22877724
• Report Number: 9615050-2025-00398
• Device Sequence Number: 10290952
• Product Code: FPA
• UDI-Device Identifier: 10887709120201
• UDI-Public: (01)10887709120201(17)280101(10)14218453
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2026

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: SF3258-15H-04
• Device Lot Number: 14218453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/24/2025; 01/14/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/19/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: UNSPECIFIED IV FLUID, MFR UNK
• Patient Sex: Unknown