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

Catalog Number MX43660

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 02/03/2015

Event Type  No Answer Provided  

Event Description

The white piece of the stopcock became dislodged and the central line was found to be leaking.

• 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: 4656917
• MDR Text Key: 16081260
• Report Number: 4656917
• 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: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• 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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2015
• Patient Sequence Number: 1
• Patient Age: 2 YR