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	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a chemoclave¿ vented vial spike 20mm where it was reported, ¿following the withdrawal of the chemotherapy drug, a fragment of the needless valve (white fragment) came out of the spike and fell inside it." there was unknown patient involvement, unknown adverse event / human harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
Additional information was received on stating there was no patient involvement and no harm reported.No physical damage was noticed before use.
Additional Manufacturer Narrative
No 011-ch-74s product samples, videos or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.The device history review for lot number 14152841 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• 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: 21862619
• Report Number: 9617594-2025-00799
• Device Sequence Number: 7898086
• Product Code: ONB
• UDI-Device Identifier: 00887709014657
• UDI-Public: (01)00887709014657(17)290901(10)14152841
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ETOPOSIDE, UNK MFR.
• Patient Sex: Unknown