MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (B; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3225
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Additional reporter information: (b)(6).
Event or Problem Description
An event involved a 14 appx 8.0 ml, quinfuse add-on set, bag spike, 5 clamps, dry spike adapter reported leakage from the end of administration set.Event was noted during infusion.An unknown chemo drug was involved in the event.There was no bleed back reported.The product is not a biohazard, and the device was not reprocessed/re sterilized.There was patient involvement but no patient harm.There was no delay in critical therapy.This report captures ten occurrences involving the same device model.No additional identifying information was available for any of the devices.
Additional Manufacturer Narrative
A photo was returned showing the drip chamber bag spike inserted into the dry spike adaptor.There was no leakage observed in the photo provided.The reported complaint could not be confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review was performed, and no nonconformities were found that would have led to the reported complaint.Updated information in d9.

• Brand Name: 14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (B
• 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: 23764914
• Report Number: 9617594-2025-02284
• Device Sequence Number: 18795393
• Product Code: ONB
• UDI-Device Identifier: 00840619025663
• UDI-Public: (01)00840619025663(17)290801(10)14124124
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: CH3225
• Device Lot Number: 14124124
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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: UNKNOWN CHEMO DRUG, UNK MFR
• Patient Sex: Unknown