MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383556

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector needle pierced through the side of the catheter while attempting to insert it into the vein.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "in our unit at xxxxx we have had three encounters within the last two weeks where the pre-attached extension set disloges from the built-in stabilization platform of the iv catheter.Also the plastic catheter split off the side of the needle as rn was trying to insert iv catheter.".

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary since no 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.H3 other text : see h10.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector needle pierced through the side of the catheter while attempting to insert it into the vein.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "in our unit at xxxxx we have had three encounters within the last two weeks where the pre-attached extension set disloges from the built-in stabilization platform of the iv catheter.Also the plastic catheter split off the side of the needle as rn was trying to insert iv catheter.".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16935355
• MDR Text Key: 315565976
• Report Number: 1710034-2023-00519
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903835560
• UDI-Public: 00382903835560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383556
• Device Lot Number: 2223266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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