MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 24 GA X 3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383511

Device Problem Difficult or Delayed Activation (2577)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that nexiva 24 ga x 3/4 in single port needle disengagement was difficult.The following information was provided by the initial reporter: during operation check before catheter placement, the hcp felt a strong resistance when withdrawing the needle.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-01.H6: investigation summary: bd received a 24 gauge nexiva unit from lot 0163980 for evaluation.A review of the device history record was performed for the reported defect and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no damage to the v-clip, grip or retaining washer that could have contributed to the reported issue.During manufacturing this type of defect can result from the process of placing the retaining washer if the washer was inserted incorrectly so that it was not able to float inside the tip shield, from mis-inserted cannula, or from misplaced adhesive.None of these were observed in the unit.Manufacturing operators perform in process sampling and functional testing for retraction throughout the manufacturing process.Functional testing was performed for the returned, while pulling the needle grip assembly back through the catheter there were no signs of drag and resistance experienced.The retaining washer moved freely as it was intended to during retraction and the needle tip was secured within the tip shield.Therefore, the defect of needle disengagement difficult was not observed or confirmed.Since the reported issue was not observed a probable root cause could not be determined.

Event Description

It was reported that nexiva 24 ga x 3/4 in single port needle disengagement was difficult.The following information was provided by the initial reporter: during operation check before catheter placement, the hcp felt a strong resistance when withdrawing the needle.

• Brand Name: NEXIVA 24 GA X 3/4 IN SINGLE PORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11335891
• MDR Text Key: 232168742
• Report Number: 1710034-2021-00113
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: 00382903835119
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 383511
• Device Lot Number: 0163980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1