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

Model Number 383576

Patient Problem Failure of Implant (1924)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

Nexiva 20 ga iv, catheter tips are kinking and folding inside of patients.Multiple rn's have experienced the same issue.

• 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 dr; franklin lakes NJ 07417
• MDR Report Key: 18317811
• MDR Text Key: 330373705
• Report Number: 18317811
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/09/2023

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 Model Number: 383576
• Device Catalogue Number: 383576
• Device Lot Number: 3131471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1