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

Catalog Number 383650

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

Patient Problems Extravasation (1842); 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 1st of 2 related incidents.The following information was provided by the initial reporter: "redness occurs at the puncture site through the entire lenght 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.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 2020-08-13.Investigation summary bd received an unused 18 gauge nexiva unit from lot 9221847 for evaluation.A review of the device history record (dhr) was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no physical/mechanical damage to the returned unit.A reaction to the product could result from contaminated unit.Per the dhr review it was noted that this unit was built, packaged and sterilized per specifications and within compliance.The device also appeared to be unused.Based off the visual inspection and dhr review the engineer was unable to verify the reported defect.Since no defect was found during evaluation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h.10.

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 1st of 2 related incidents.The following information was provided by the initial reporter: "redness occurs at the puncture site through the entire lenght of the catheter.Moreover, area outside of the fixative is also red what is supported by the image from the attachment.Futhermore, 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, adiministration of antibiotics.

• 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: 10258916
• MDR Text Key: 198786077
• Report Number: 1710034-2020-00440
• 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: 09/01/2020

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: 07/31/2022
• Device Catalogue Number: 383650
• Device Lot Number: 9221847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• 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: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention