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

Model Number	CH-70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event involved a chemoclave® universal vented vial spike that during aspiration, using a syringe of oxaliplatin, a leak was noted from the spike contaminating the work area hood and the operator¿s forearm¿.There is patient involvement, and no harm was reported.

• Brand Name: CHEMOCLAVE® UNIVERSAL VENTED VIAL SPIKE
• 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: 9670691
• Report Number: 9617594-2020-00034
• Device Sequence Number: 18920886
• Product Code: ONB
• UDI-Device Identifier: 00840619025854
• UDI-Public: (01)00840619025854(17)240901(10)4375468
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: 09/01/2024
• Device Model Number: CH-70
• Device Catalogue Number: CH-70
• Device Lot Number: 4375468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1