MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383516

Device Problem Defective Component (2292)

Patient Problem Burning Sensation (2146)

Event Date 04/08/2023

Event Type  malfunction  

Event Description

It was reported while using bd nexiva¿ closed iv catheter system - single port the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: 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.

Manufacturer Narrative

E.4.: the initial reporter also notified the fda on 18apr2023.Medwatch report # mw5116900.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system - single port the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: 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 PORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17007620
• MDR Text Key: 316720677
• Report Number: 1710034-2023-00568
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835164
• UDI-Public: (01)00382903835164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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: Other
• Device Catalogue Number: 383516
• Device Lot Number: 2361289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1