MAUDE Adverse Event Report: BD BD NEXIVA; IV NEEDLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolus (1830)

Event Date 06/07/2017

Event Type  Injury  

Event Description

Ct exams with issue, approx 3 hours after exams, radiologist when reading exam noted air embolus.

• Brand Name: BD NEXIVA
• Type of Device: IV NEEDLE
• Manufacturer (Section D): BD
• MDR Report Key: 6633139
• MDR Text Key: 77429377
• Report Number: MW5070293
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 139