MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros¿, Bag Spike, 4 Clamps (B; closed antineoplastic and hazardous drug reconstitution and transfer system

Catalog Number	CH3226
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 20" (51 cm) appx 9.5 ml, quadfuse add-on set w/3 spiros, bag spike, 4 clamps (blue, 3 red), dry spike adapter.The reporter stated leakaged from spiro (1 incident occurred.) the event occurred during infusion.There was no concomitant drug and no concomitant device.There was no bleedback, with chemo, no biohazard, no user facility medwatch and no device was reprocessed/resterilized.Sample is available for investigation.There was patient involvement, no adverse event/patient harm, and no delay in critical therapy.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1 - initial reporter phone is (b)(6).

• Brand Name: 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros¿, Bag Spike, 4 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50801654
• Report Number: 9617594-2026-01289
• Device Sequence Number: 8644172
• Product Code: ONB
• UDI-Device Identifier: 00840619025670
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: CH3226
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown