MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. ChemoClave® Bag Spike with Additive Port; closed antineoplastic and hazardous drug reconstitution and transfer system

Catalog Number	CH-13
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction

• Brand Name: ChemoClave® Bag Spike with Additive Port
• 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: 50677042
• Report Number: 9617594-2026-01210
• Device Sequence Number: 10423982
• Product Code: ONB
• UDI-Device Identifier: 00840619023737
• UDI-Public: (01)00840619023737(17)301001(10)14757888
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• 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,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: CH-13
• Device Lot Number: 14757888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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