MAUDE Adverse Event Report: BD BD NEXIVA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 383516

Device Problems Retraction Problem (1536); Separation Failure (2547)

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

Event Date 12/14/2022

Event Type  Injury  

Event Description

Safety device/insertion needle on bd nexiva would not retract from device all the way after use with pt (patient) during normal use.Safety device engaged but was not able to separate from the iv catheter.Team member did not maintain malfunctioning device.No injury to patient or team member.

• Brand Name: BD NEXIVA
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD; 1 becton drive,; franklin lakes NJ 07417
• MDR Report Key: 16086086
• MDR Text Key: 306677319
• Report Number: MW5114131
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2022

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: Health Professional
• Device Model Number: 383516
• Device Catalogue Number: 383516
• Device Lot Number: 2265651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other