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

Model Number	383576
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 13479893
• Device Sequence Number: 14755149
• Product Code: FOZ
• UDI-Device Identifier: 00382903835768
• UDI-Public: (01)00382903835768
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2022
• Report Date (Section F): 01/07/2022

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
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/07/2022