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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a chemoclave® bag spike with additive port dry spike where the customer reported that the paper film inside the spike came out into the medication bags.It is unknown if there is patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of the paper coming into the spike could not be confirmed.Without the return of the sample or a photo/video 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.D9 - device available for evaluation: no.

• 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: 21768346
• Report Number: 9617594-2025-00643
• Device Sequence Number: 18265299
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: (01)00840619023713(17)290101(10)13890965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2025

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: 13890965
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 11/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Patient Sex: Unknown