MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. NEXIVA 24 G 3/4 INCH

Model Number NEXIVA

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

Bd nexiva 24 gauge ref (b)(4).Lot #4112626 placed in patient's vein.Blood leaked from the junction of the needle tip shield and the tip of the triangled stabilization platform evincing a break in the system.Diagnosis or reason for use: venous access for iv antibiotics.

• Brand Name: NEXIVA 24 G 3/4 INCH
• Type of Device: NEXIVA 24 G 3/4 INCH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; franklin lakes NJ 07417
• MDR Report Key: 4699644
• MDR Text Key: 5647985
• Report Number: MW5042106
• Device Sequence Number: 1
• Product Code: FMI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: NEXIVA
• Device Catalogue Number: REF 383511
• Device Lot Number: 4112626
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BECTON DICKINSON 22 GAUGE ONE INCH INSYTE CATHETER