MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383516

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on 23 september, 2021.Medwatch report # mw5104006.Report source other: medwatch report.Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that nexiva 20 ga x 1 in single port adaptor could not be removed.The following information was provided by the initial reporter: it was reported by the medical professional, they were unable to remove the adaptor from the iv hub.  mw5104006.Unable to remove an adaptor from n iv hub.Staff tried to ise hemostt to remove the adapter when the plastic began to tear leaving adaptor lodged in iv hub.Iv needed to be removed and restarted.

• Brand Name: NEXIVA 20 GA X 1 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: 12715368
• MDR Text Key: 280111010
• Report Number: 1710034-2021-00927
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835164
• UDI-Public: 00382903835164
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: 1119129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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