MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET

Model Number	MX4341L
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While connected to the pain pump tubing, noted the ports on the stopcock were leaking.

• Brand Name: MEDEX
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 7742158
• Report Number: 7742158
• Device Sequence Number: 1366109
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: (01)10351688507648(11)170731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/17/2018
• Report Date (Section F): 07/17/2018

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: No Information
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 3453709
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/17/2018