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	CH-74S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is available for investigation.It is yet to be received.
Event or Problem Description
The event involved a chemoclave vented vial spike that the filter disconnected from the spike.The leakage of fluorouracil resulted in contamination of the work station and loss of drugs.There was no patient involvement, no adverse event, and no delay in critical therapy.
Additional Manufacturer Narrative
No product samples were returned and no photographs or videos were provided for investigation.Therefore, a comprehensive failure investigation was unable to be performed and a probable cause cannot be identified based on the information provided.A device history review (dhr) for lot# 3937220 and relevant components review was conducted and there were no relevant 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
• MDR Report Key: 8484292
• Report Number: 9617594-2019-00105
• Device Sequence Number: 1922353
• Product Code: ONB
• UDI-Device Identifier: 00840619065577
• UDI-Public: (01)00840619065577(17)240101(10)3937220
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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 Expiration Date: 01/01/2024
• Device Catalogue Number: CH-74S
• Device Lot Number: 3937220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL.