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 Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation: it has been discarded.The investigation is pending.
Event or Problem Description
The event involved a secondary set 34 inch with iv set hanger, secure lock where it was reported that zofran infusion was leaking.Infusion stopped secondary iv set noted to have a hole in the tubing.The leak occurred on an iv pump and was cleaned per hospital protocol.There was no patient harm but there was slight delay in therapy while switching out the set.
Additional Manufacturer Narrative
Received three photos from the customer.One photo of the set, one photo of the packaging, and one photo of the cut tubing.The cut was straight and clean.The complaint of leakage can be confirmed based on cut tubing.The probable cause is due to interactions with a sharp object.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in e3 - initial reporter occupation, e4 - initial report sent to fda and h6 health effect - impact code.

• 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: 23328008
• Report Number: 9615050-2025-00483
• Device Sequence Number: 18784794
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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: UNSPECIFIED IV PUMP, MFR UNK.; ZOFRAN, MFR UNK.
• Patient Sex: Unknown