MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; 3 WAY STOPCOCK

Catalog Number MX43660

Device Problems Air Leak (1008); Break (1069)

Patient Problem No Information (3190)

Event Date 01/24/2015

Event Type  No Answer Provided  

Event Description

The transduced right internal jugular (ij) line part of the line, where the white turning valve is located, popped off as a flush/medication was running through and the valve was being turned to open.Ij was being transduced and a medication was infusing.It popped right off and air entered the line.The line was immediately clamped off to the patient and the medication was stopped.A new set up was then used.

• Brand Name: MEDEX
• Type of Device: 3 WAY STOPCOCK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 4656875
• MDR Text Key: 5733224
• Report Number: 4656875
• Device Sequence Number: 1
• Product Code: FMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Device Catalogue Number: MX43660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2015
• Patient Sequence Number: 1
• Patient Age: 1 YR