MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 383519

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

Needle port valve failed.Started an iv for a ct scan and there was blood coming out of the needle port.Flushed iv with a saline and the saline also leaked out from the needle port.A new iv was started.

• Brand Name: BD NEXIVA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12300522
• MDR Text Key: 265813928
• Report Number: 12300522
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383519
• Device Catalogue Number: 383519
• Device Lot Number: 1067212
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1