MAUDE Adverse Event Report: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number 383541

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Exposure to Body Fluids (1745); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported bd nexiva¿ closed iv catheter system - dual port 24 ga 0.75 in had an unknown issue.The following information was provided by the initial reporter: "incident number: (b)(4)".

Manufacturer Narrative

H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly. our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported bd nexiva¿ closed iv catheter system - dual port 24 ga 0.75 in had an unknown issue.The following information was provided by the initial reporter: "incident number: (b)(4).".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12328479
• MDR Text Key: 266849533
• Report Number: 9610847-2021-00373
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383541
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other