MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	011-CH-74S
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	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a chemoclave¿ vented vial spike, 20mm.The reporter stated that particles were observed after preparation of incmga00012 500 mg/20 ml à 500mg dilute in 100ml nacl 0.9%.This also was observed with ¿study medications¿ that they been preparing for a longer time.There was no report of any human harm.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Lot history review was performed and no nonconformities were found that would have led to the reported complaint.Additional information - b3, b5, d9.
Event or Problem Description
Additional information was received where the customer stated that after preparation particles are visible in the iv bag.They study chemo for new drug that is not already on the market.They are not sure which of the device can be the cause of those particles but they are assuming that it could be the silicone oil.There was no serious injury, no blood loss, no unprotected chemo exposure, no adverse operator consequences, and no med/surg intervention required.The device was changed out/replaced with no further problems encountered.It was detected prior to direct patient use.

• Brand Name: CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM
• 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: 21767689
• Report Number: 9617594-2025-00639
• Device Sequence Number: 8721584
• Product Code: ONB
• UDI-Device Identifier: 00887709014657
• UDI-Public: (01)00887709014657(17)290901(10)14152841
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 011-CH-74S
• Device Lot Number: 14152841
• 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: 04/08/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 500 MG/20 ML À 500MG VERDUNNEN IN 100ML NACL 0.9%
• Patient Sex: Unknown