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

Model Number	CL-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer indicated that the device is not available for testing.
Event or Problem Description
The event involved a chemolock¿ bag spike and the customer stated that the iv set came out of the iv bag when the user went to remove it from the biohazard bag, resulting in a spill of an unspecified chemo drug.The spill occurred in the patient¿s room, there was patient involvement and a delay in therapy, however, there was no one harmed as a result of the event.
Event or Problem Description
An update was received from the customer on (b)(6) 2020 stating that the bag that was sent to the floor and caused a spill in the patient's room was a d5w 250ml.
Additional Manufacturer Narrative
Additional information found in b5.H10: no product samples, videos, or photographs were returned for investigation.The dhr for lot 4346557 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, DRY 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: 9475867
• Report Number: 9617594-2019-00425
• Device Sequence Number: 2790825
• Product Code: ONB
• UDI-Device Identifier: 00887709056978
• UDI-Public: (01)00887709056978(17)240801(10)4346557
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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: 08/01/2024
• Device Model Number: CL-12
• Device Catalogue Number: CL-12
• Device Lot Number: 4346557
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1