MAUDE Adverse Event Report: BD BD CONNECTA 3-WAY STOPCOCK WITH BD Q-SYTE

Catalog Number 394501

Device Problem Fluid/Blood Leak (1250)

Patient Problem Sedation (2368)

Event Date 07/04/2014

Event Type  Injury  

Event Description

The bd connecta device leaked, causing the sedated patient to wake up during the procedure.Application of a new stopcock was necessary and the patient had to be adequately sedated a second time.

Manufacturer Narrative

The sample is available for evaluation.Upon receipt of the sample and completion of the investigation, a supplemental report will be submitted.

• Brand Name: BD CONNECTA 3-WAY STOPCOCK WITH BD Q-SYTE
• Type of Device: 3-WAY STOPCOCK
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: amy bodell ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652585
• MDR Report Key: 3981140
• MDR Text Key: 4820122
• Report Number: 2243072-2014-00152
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 394501
• Device Lot Number: 3275095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: LIPIDS
• Patient Outcome(s): Required Intervention