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	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.The investigation is pending.
Event or Problem Description
The reported complaint involved a chemoclave¿ vented vial spike, 20mm.Particles were reported in an infusion bag using pembrolizumab (from foreign distributor servier bulgaria) in nacl 0.9% 100 ml infusion during a clinical study.The particles formed upon time of dilution of the concentrated pembrolizumab into a saline infusion bag.Infusion was prepared a second time with new pembro vials, whereby particles were observed again.Infusion was prepared a third time, this time with syringe and needle and no particles observed.No serious injury/death, no blood loss, no unprotected chemo exposure.No adverse operator consequences.No med/surg intervention required.The device was changed out/replaced with no further problems encountered.The involved patient was not harmed, there was only delay of therapy and infusion bag with particles was not dispensed nor administered.
Additional Manufacturer Narrative
D9 - device available for evaluation - updated to no.Investigation summary the reported complaint of particles 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 and no nonconformities were identified that may 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: 22324563
• Report Number: 9617594-2025-01337
• Device Sequence Number: 13017695
• Product Code: ONB
• UDI-Device Identifier: 00887709014657
• UDI-Public: (01)00887709014657(17)291001(10)14179567
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 14179567
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: NACL 0.9% 100 ML BAG, MFR UNK.; PEMBROLIZUMAB, MFR UNK.
• Patient Sex: Unknown