MAUDE Adverse Event Report: BECTON DICKINSON BD CONNECTA PLUS 3 WAY STOPCOCK

Catalog Number 394995

Device Problem Disconnection (1171)

Patient Problems Respiratory Distress (2045); Skin Discoloration (2074); Loss of consciousness (2418)

Event Date 10/29/2014

Event Type  Injury  

Manufacturer Narrative

Results - a sample was not received for evaluation and a lot number for this device was not provided.Without a lot number for this device a review of the device history records could not be performed.Conclusion: without a sample, a root cause for this incident could not be identified.

Event Description

It was reported that a bd connecta plus 3-way stopcock was attached to a patient's right subclavian tunneled catheter and found disconnected.The patient was found in a state of acute respiratory distress with altered level of consciousness and mottling.At that time an aspiration of the catheter showed no presence of air and the patient received a lung and brain scan to rule out a possible air embolism.The patient was then transferred to the intensive care unit and received hyperbaric chamber therapy.Of note, it was also reported that on (b)(6) 2013 a similar episode in which the patient's catheter became disconnected from the bd connecta plus 3-way stopcock while the medical staff was getting the patient up.There was no report of serious injury or medical intervention at that time.

• Brand Name: BD CONNECTA PLUS 3 WAY STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417 188
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417-1880 ; 8015652406
• MDR Report Key: 4279021
• MDR Text Key: 15954238
• Report Number: 2243072-2014-00290
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 394995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention