MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL-13
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is not available for evaluation.It was disposed of with the bulk chemotherapy waste from the spill kit.
Event or Problem Description
A sus voluntary event report (mw5087812) was received, which stated the following " chemolock cl-13 bag spike slid completely out of 250 ml normal saline bag containing chemotherapy.This resulted in exposure and a chemotherapy spill response.The bag spike was confirmed to be completed seated by the pharmacist completing admixture.Nurse that started administration process did not pull on the connection; however, when hanging the bag, the spike slid out resulting in a hd spill.¿.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT
• 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: 8902587
• Report Number: 9617594-2019-00277
• Device Sequence Number: 16695978
• Product Code: ONB
• UDI-Device Identifier: 00887709056985
• UDI-Public: (01)00887709056985(17)240501(10)4091142
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: 05/01/2024
• Device Model Number: CL-13
• Device Catalogue Number: CL-13
• Device Lot Number: 4091142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1