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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.The device history report will be reviewed.
Event or Problem Description
The event involved secondary set 34 inch with iv set hanger, secure lock where it was reported that chemo would not flow out of the secondary set while using the bd alaris pump and set.There was patient involvement, no patient harm but there was a delay in therapy.
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.

• 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: 23290790
• Report Number: 9615050-2025-00473
• Device Sequence Number: 20049172
• Product Code: FPA
• UDI-Device Identifier: 10887709120201
• UDI-Public: (01)10887709120201(17)271201(10)14216689
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 14216689
• 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
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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: BD ALARIS PUMP, MFR UNK.; UNSPECIFIED CHEMO, MFR UNK.
• Patient Sex: Unknown