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

Catalog Number 383647

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Venipuncture (2129)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that redness occurred at the puncture site through the entire length of the bd nexiva¿ closed iv catheter system, causing extravasations that were mainly noticed on the third day of placement.An "x-ray, ct scan, magnet, gastroscopy, and ercp" were performed, antibiotics given, and the catheter was replaced.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "redness occurs at the puncture site through the entire length of the catheter.Moreover, area outside of the fixative is also red what is supported by the image.Furthermore, they also noticed and monitored extravasations due to the insertion of catheter.These situations mostly arises on third day of the catheter insertion which force nurses to replace the catheter." "x-ray, ct scan, magnet, gastroscopy, ercp, administration of antibiotics.".

Event Description

It was reported that redness occurred at the puncture site through the entire length of the bd nexiva¿ closed iv catheter system, causing extravasations that were mainly noticed on the third day of placement.An "x-ray, ct scan, magnet, gastroscopy, and ercp" were performed, antibiotics given, and the catheter was replaced.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "redness occurs at the puncture site through the entire length of the catheter.Moreover, area outside of the fixative is also red what is supported by the image from the attachment.Furthermore, they also noticed and monitored extravasations due to the insertion of catheter.These situations mostly arises on third day of the catheter insertion which force nurses to replace the catheter." "x-ray, ct scan, magnet, gastroscopy, ercp, administration of antibiotics.".

Manufacturer Narrative

H.6.Investigation summary a physical sample was not available for investigation but bd was provided with three photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 9221847, and no quality issues were found during production.The lot was documented as being properly sterilized with no issues observed.Our quality engineer reviewed the provided photos and observed a 20 gauge nexiva unit in use with a transparent dressing placed over the insertion site.There are traces of media present at the insertion site and down a portion of the extension line indicating a successful activation.However, there is also visible redness at the insertion site that runs partially up the arm.Based off the provided photos the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be determined without a physical sample available for testing.It was also reported that extravasations were observed and monitored due to the insertion.This could be a contributing factor as well.The manufacturing facility has been notified of this incident and the findings.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10258917
• MDR Text Key: 198786160
• Report Number: 1710034-2020-00439
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 383647
• Device Lot Number: 9284508
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/20/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention