MAUDE Adverse Event Report: BD BD CONNECTA 3-WAY STOPCOCK WITH BD Q-STYLE; LUER ACCESS SPLIT SEPTUM DEVICE

Catalog Number 394501

Device Problem Fluid/Blood Leak (1250)

Patient Problems Exposure to Body Fluids (1745); Underdose (2542)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that while using a bd connecta 3-way stopcock with bd q-style during a sedation procedure for a fractured body part, that the medication, propofol, began leaking from the bd q-style exposing the pt and the clinician to blood and medication.The propofol leak caused the pt to wake up during the sedation procedure.The bd q-style was changed on the pt's iv line and as of this date there has been no further report of additional medical interventions or adverse events for either the pt or the clinician.

Manufacturer Narrative

The sample is available for eval.Upon completion of the investigation, a supplemental report will be filed.Of note, multiple attempts have been made to obtain additional info and no further info is available.A quality notification review was done on the reported lot number 3092105b57 and no irregularities were found.(b)(4).

• Brand Name: BD CONNECTA 3-WAY STOPCOCK WITH BD Q-STYLE
• Type of Device: LUER ACCESS SPLIT SEPTUM DEVICE
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4230388
• MDR Text Key: 4975878
• Report Number: 2243072-2014-00264
• 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,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 394501
• Device Lot Number: 3092105B7
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2014
• Date Manufacturer Received: 09/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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
• Patient Outcome(s): Other