MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3187
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
The event involved 15" (38 cm) appx 5.2 ml, bifuse add-on set w/bag spike, spiros¿, 3 clamps (blue, red, white), dry spike adapter where it was reported that a chemotherapy drug leaked at the connection site during infusion.There was patient involvement but no patient harm.There was no delay in critical therapy.
Additional Manufacturer Narrative
The device was received for evaluation on 9/25/2025.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample was tested, and a leak was observed through the filter.The probable cause of the leak is from the temporary loss of hydrophobic properties.Lot history review was conducted, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23294164
• Report Number: 9617594-2025-01987
• Device Sequence Number: 4783439
• Product Code: ONB
• UDI-Device Identifier: 00840619025335
• UDI-Public: (01)00840619025335(17)290601(10)14045176
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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: CH3187
• Device Lot Number: 14045176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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 CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown