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

Catalog Number	CH-51
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Operators observed a particulate in vial 1 of 7 of viral vector fin v20006 v1.3 symb (global) prior to withdrawing the required volume for mvp 1 when using the universal vented vial spike, clave®.This occurred during the media virus protamine sulfate (mvp) pack aliquot glb4 200 formulation.The vial had been inspected by the operator per (b)(4), cto network visual integrity check before spiking.It was therefore surmised that a portion of the vial septum sheared off after being spiked with the vented vial spike.In addition, the customer stated that per (b)(4), characterization of particulate in viral vector vial from bothell, particle analysis confirmed the particle was morphologically and chemically consistent with the septum of the viral vector vial.There was no patient involvement and no harm.
Additional Manufacturer Narrative
Complaint of particulate matter on item ch-51 cannot be confirmed.Since 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 probable cause cannot be determined.The dhr lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: UNIVERSAL VENTED VIAL SPIKE, CLAVE®
• 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: 24283930
• Report Number: 9617594-2026-00090
• Device Sequence Number: 18284986
• Product Code: ONB
• UDI-Device Identifier: 00840619025779
• UDI-Public: (01)00840619025779(17)291001(10)14179079
• Combination Product (Y/N): N
• 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: Other,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: CH-51
• Device Lot Number: 14179079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: MEDIA VIRUS PROTAMINE SULFATE (MVP), MFR UNK; VECTOR FIN V20006 V1.3 SYMB, MFR UNK
• Patient Sex: Unknown