MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 383516

Device Problems Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problem Burning Sensation (2146)

Event Date 04/08/2023

Event Type  malfunction  

Event Description

Patient's iv tubing ruptured while iv contrast was being administered.Patient stated she was feeling a burning sensation at the injection site just prior to the tubing failing.She has had prior injections of contrast and experienced burning sensation but no other problems.Patient commented she saw the tubing stat to expand when the burning started in her arm and the tubing burst quickly there after.Checked arm/injection site for extravasation/injury, none noted.Patient denied any discomfort.The patient had received a portion of the contrast before the iv failed by rupturing.The iv was not clamped and was open to receive the desired dose of medication.It is unknown how much of the contrast was given to the patient before the iv failed.Note: red mark on tubing is where the tubing bubbled and then split.Psi on power injector was set to 325psi.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 16790447
• MDR Text Key: 313836263
• Report Number: MW5116900
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2023

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: 383516
• Device Lot Number: 2361289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1