MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NEXIVA CLOSED IV CATHETER SYSTEM-DUAL PORT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Catalog Number 383536

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2015

Event Type  malfunction  

Event Description

Since about six months ago this year, we have experienced four events with the nexiva closed iv catheter system.About six months ago, we had a failure with the catheter system ballooning during use with a power injector that was previously reported.During this month alone, we have experienced three events.The first report this month involved not being able to remove the needle after insertion of the iv catheter.This event happened in er and was recently reported.Then we had a second event; ballooning of the tubing while using a power injector.The nurse described the event: "during infusion of iv contrast at ct, flow stopped as the pressure on the infuser increased.It was then noticed that the iv tubing had expanded.The infuser was turned off and as the pressure dissipated, flow began again.No injury or infiltration was noted in the patient." this event occurred in ct.Again this month we had the issue of not being able to remove the needle after insertion of the iv catheter.This event was described as such: "after iv was started on patient, while pulling the needle out, needle got stuck half way and never came out.Three other rn's tried to pull needle out, but were unable to.Rn had to discontinue iv and start a second one, due to this malfunction." this event happened in same day surgery.The three events in (b)(6) are related to the same lot number of 5240856.

• Brand Name: NEXIVA CLOSED IV CATHETER SYSTEM-DUAL PORT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 5331604
• MDR Text Key: 34543349
• Report Number: 5331604
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 383536
• Device Lot Number: 5240856
• 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: 12/21/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR