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

Catalog Number MX43660

Device Problems Air Leak (1008); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

The nurse (rn) went to flush the external jugular line which had the following connections: jelco t connector without clamp, but built in stop cock.The nurse turned the stop cock to flush the port and the white stop cock dislodged from its hub.Attempts were made to replace the stop cock failed and the line was lost.The equipment was saved and labeled for analysis.The problem occurs when the moveable white piece of the stopcock becomes dislodged from the tubing.The system becomes open to air and anything infusing into the patient leaks and does not reach the patient.

• 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: 4656934
• MDR Text Key: 16849219
• Report Number: 4656934
• 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?: Yes
• Device Operator: Nurse
• Device Catalogue Number: MX43660
• Was Device Available for Evaluation?: Yes
• 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
• Treatment: NO-CONNECTED TO IV LINE
• Patient Age: 1 DAY