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

Model Number 383576

Device Problems Material Protrusion/Extrusion (2979); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Iv was started using 20g bd nexiva closed iv catheter.After iv was started and needle was disconnected from catheter, needle came out exposed and not protected.

• 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: 13479893
• MDR Text Key: 285235072
• Report Number: 13479893
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835768
• UDI-Public: (01)00382903835768
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383576
• Device Catalogue Number: 383576
• Device Lot Number: 0300545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1