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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
The customer reported difficulties with chemoclave¿ vented vial spike, 20mm when preparing cytotoxic oily drugs (paclitaxel, docetaxel, etoposide) across all devices used in recent months.Specifically, the malfunction resulted in drug leakage.The spill did not involve the patient, however, the spill came into contact with the healthcare worker.The device additionally failed to equalize the pressure inside the vial, preventing the correct amount of medication from being drawn.Although there were no injuries or deaths related to the malfunction, the issue resulted in delays in the preparation of therapy.No medical intervention was required.The affected drugs have been replaced.The spilled material was cleaned according to facility protocol, a specific kit was not used.The actual specific event date was not provided.There was no human harm.
Additional Manufacturer Narrative
Photos were returned showing the boxes and packaging information.No defects or anomalies noted.However, the complaint can be confirmed based on the device and complaint information.The probable cause of the restricted flow is due to a vendor related issue.The lot was found to fall under the scope of corrective and preventative action (capa) a capa plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized.

• 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: 24619854
• Report Number: 9617594-2026-00281
• Device Sequence Number: 15986908
• Product Code: ONB
• UDI-Device Identifier: 00887709014657
• UDI-Public: (01)00887709014657(17)300201(10)14295188
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 011-CH-74S
• Device Lot Number: 14295188
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DOCETAXEL, MFR UNK.; ETOPOSIDE, MFR UNK.; PACLITAXEL, MFR UNK.
• Patient Sex: Unknown