MAUDE Adverse Event Report: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383512

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

The reported lot # 1035216 was not found for the reported catalog # 383512.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 that 20 bd nexiva¿ closed iv catheter systems had no label.The following information was provided by the initial reporter: "product label is missing".

Event Description

It was reported that 20 bd nexiva¿ closed iv catheter systems had no label.The following information was provided by the initial reporter: "product label is missing.".

Manufacturer Narrative

The following fields were updated due to additional information: d4: catalog # 383532, d4: medical device lot #: 1035216, d4: medical device expiration date: 2024-01-31, d4: udi # (b)(4), g.5.Pma / 510(k)#: k102520, h4: device manufacture date: 2021-02-04.H6: investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1035216, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed a nexiva dispenser box with a missing label.Based off the provided photo the engineer was able to verify the reported defect.Dispense labels are either placed by the packaging operators or by an automated system using a vision system to detect for any missing labels.It was determined that this was an operator error.The manufacturing facility has been notified of this incident and the findings.A notification was issued to all packaging operators to raise awareness of this incident and prevent recurrence.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12072224
• MDR Text Key: 265816218
• Report Number: 1710034-2021-00529
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• Combination Product (y/n): N
• PMA/PMN Number: K102520
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 383512
• Device Catalogue Number: 383532
• Device Lot Number: 1035216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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