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

Model Number MX4341L

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 07/16/2018

Event Type  malfunction  

Event Description

While connected to the pain pump tubing, noted the ports on the stopcock were leaking.

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 7742158
• MDR Text Key: 115797412
• Report Number: 7742158
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: (01)10351688507648(11)170731
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 3453709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1