MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM¿SINGLE PORT WITH BD MAXZERO¿; INTRAVASCULAR CATHETER

Model Number 383556

Device Problem Leak/Splash (1354)

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

Event Date 01/07/2022

Event Type  malfunction  

Event Description

It was reported that while using a bd nexiva¿ closed iv catheter system¿single port with bd maxzero¿ needle-free connector leakage occurred.The following information was provided by the initial reporter: the nexiva catheter was faulty/leaking blood at bifurcation causing the patient to have to be re-stuck for iv access.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using a bd nexiva¿ closed iv catheter system¿single port with bd maxzero¿ needle-free connector leakage occurred.The following information was provided by the initial reporter: the nexiva catheter was faulty/leaking blood at bifurication causing the patient to have to be re-stuck for iv access.

Manufacturer Narrative

H.6.Investigation: 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 h.10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM¿SINGLE PORT WITH BD MAXZERO¿
• Type of Device: INTRAVASCULAR CATHETER
• 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 ; 8015296192
• MDR Report Key: 13581855
• MDR Text Key: 286497776
• Report Number: 1710034-2022-00089
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835561
• UDI-Public: 30382903835561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383556
• Device Catalogue Number: 383556
• Device Lot Number: 1287556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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