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

Model Number 383517

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: nexiva is very attached, when removing the bezel a squeak is heard and has caused insecurity of use in the areas.

Manufacturer Narrative

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

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 21-feb-2023.H6.Investigation summary: bd received a 20 gauge nexiva device from lot 2122704 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed that the unit had been used.The needle had also decoupled from the catheter.Next, the engineer attempted to recreate the reported issue by resetting the cannula when a scrapping noise was heard.Further investigation determined that the scrapping noise was the washer rubbing against the needle creating friction.The engineer attempted to retract the needle but experienced resistance during the entirety of the retraction process.After retraction, the engineer dissected the device to investigate the washer further.The washer was measured and found to be outside of product specifications.Finally, an inspection of the incoming raw materials process was performed and a raw material engineer was contacted to ensure the certificate of compliance was received for the batch of washers issued for the finished good lot.While looking at the compliance for the raw material report, it was discovered that all the paperwork was completed correctly by the vendor.Therefore, based off the visual inspection and testing the engineer was able to verify the reported defect.It was determined that this issue was caused by the washer being out of specifications.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: nexiva is very attached, when removing the bezel a squeak is heard and has caused insecurity of use in the areas.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: nexiva is very attached, when removing the bezel a squeak is heard and has caused insecurity of use in the areas.

Manufacturer Narrative

H6: investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.Our quality engineer reviewed the provided photo and observed the packaging labeling only.The actual device was not visible for review.Therefore, based off the provided photo the engineer was unable to verify the reported defect.Since no defects could be identified in the provided photo the engineer could not determine a definitive root cause.The dhr for lot 2122704 has been reviewed.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS 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 ; 8015296192
• MDR Report Key: 15934359
• MDR Text Key: 308083986
• Report Number: 1710034-2022-00759
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 50382903835176
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K183399
• 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,Followup
• Report Date: 03/10/2023

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 Model Number: 383517
• Device Catalogue Number: 383517
• Device Lot Number: 2122704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/26/2023; 03/10/2023
• Supplement Dates FDA Received: 02/08/2023; 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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