MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH-12
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).The device is not available for evaluation; however, lot history review will be performed.
Event or Problem Description
The event involved a chemoclave® bag spike with additive port dry spike where the customer reported that after connecting the saline solution, the spike, and the macro set, particles were observed in the device cup.The nursing technician reported that she uses the reported product connected to the baxter serum, which, according to her, does not have white plastic components, and then connects the braun set, which, according to her, whose needle tip is thicker and more pointed.In addition, it was said that, to ensure proper fitting and avoid disconnections, it is necessary to apply a certain amount of force to the connection between the ch-12 and the set.Additionally, it was stated that the braun set also does not have white parts that could justify the presence of particles.The event occurred during the preparation of the infusion, and it did not occur during patient use, there was no one harmed, no delay in therapy or adverse event as a result of this event.The incident did not contribute to a permanent or serious temporary injury, nor did it lead to or prolong the patient's hospitalization, and there was also no medical intervention.
Additional Manufacturer Narrative
Investigation summary: the reported complaints of particles could not be confirmed.No conclusions could be made from the photos and videos provided.Without the return of the sample a comprehensive review cannot be performed, and a probable cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE
• 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: 22690010
• Report Number: 9617594-2025-01587
• Device Sequence Number: 12825779
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: (01)00840619023713(17)270501(10)5997931
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: CH-12
• Device Lot Number: 5997931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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: ADMINISTRATION SET, BRAUN; SALINE SOLUTION, MFR UNK; SERUM, BAXTER
• Patient Sex: Unknown