MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® UNIVERSAL VENTED VIAL SPIKE, 5 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH-70-5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device return has been requested, however, no device has been received for an investigation.If additional information becomes available a supplemental report will be submitted.
Event or Problem Description
The event involved a leak of chemotherapy during use of a chemoclave® universal vented vial spike.The reporter stated that upon mixing 5-fluorouracil from the vial adapter, medication sprayed from the vented system towards the customer.A bd syringe was also used.There was no patient involvement and no one was harmed as a result of the reported event.
Additional Manufacturer Narrative
H10: one (1) used partial 2 units, list# ch-70-5, chemoclave® universal vented vial spike, (b)(4) units.Lot# 4168017 were returned to the manufacturer on (b)(6)2020.The complaint of leakage on the returned used two (2) units of the partially returned used ch-70-5 can be confirmed.As received there were residuals inside the filter of the of both of the two (2) units.Each device was attached to a sodium chloride vial and 10 ml syringe provided by icu medical, it was then aspirated and infused multiple times per package instructions.No leakage was anywhere along the fluid path however, the residuals inside the filter of the returned used devices indicates being infused with the vial inverted.The probable cause of leakage is due to being infused while inverted during use.The dhr for lot 4168017 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: CHEMOCLAVE® UNIVERSAL VENTED VIAL SPIKE, 5 UNITS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 9401926
• Report Number: 9617594-2019-00413
• Device Sequence Number: 11506642
• Product Code: FPA
• UDI-Device Identifier: 00840619051747
• UDI-Public: (01)00840619051747(17)240701(10)4168017
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 07/01/2024
• Device Catalogue Number: CH-70-5
• Device Lot Number: 4168017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/24/2020
• 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: 5-FLUOROURACIL, MFR UNK; BD SYRINGE