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

Model Number 383571

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

About to start an iv using a 24 gauge iv, when i noticed that the catheter covered the entire needle.Normally, the needle tip extends out the catheter.

• 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: 19212483
• MDR Text Key: 341381910
• Report Number: 19212483
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

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: 383571
• Device Catalogue Number: 383571
• Device Lot Number: 3178935
• 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: 02/12/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/30/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other