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

Model Number 383539

Device Problem Leak/Splash (1354)

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

Event Date 11/22/2021

Event Type  malfunction  

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.

Event Description

It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced leakage when the tubing separated from the adapter/connector.The following information was provided by the initial reporter.The customer stated: we had an iv malfunction a few weeks ago.Rn placed iv, no concerns noted upon placement, proper backflow noted within closed system.Rn went to flush the iv before initiating iv fluids and the system disconnected, allowing blood to flow freely from the tubing.

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.

Event Description

It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced leakage when the tubing separated from the adapter/connector.The following information was provided by the initial reporter.The customer stated: we had an iv malfunction a few weeks ago.Rn placed iv, no concerns noted upon placement, proper backflow noted within closed system.Rn went to flush the iv before initiating iv fluids and the system disconnected, allowing blood to flow freely from the tubing.

Event Description

It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced leakage when the tubing separated from the adapter/connector.The following information was provided by the initial reporter.The customer stated: we had an iv malfunction a few weeks ago.Rn placed iv, no concerns noted upon placement, proper backflow noted within closed system.Rn went to flush the iv before initiating iv fluids and the system disconnected, allowing blood to flow freely from the tubing.

Manufacturer Narrative

Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photos.Upon inspection of the photos, there was a partial view of the device that provided enough evidence to confirm the report of separation of the adapter from tubing.No further investigation could be performed in the absence of a physical device or more detailed photos of complete unit.This type of defect can originate both in manufacturing and in user environment.Although the reported defect was confirmed, bd was unable to determine which scenario was more likely.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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: 13046540
• MDR Text Key: 285810209
• Report Number: 1710034-2021-01065
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835394
• UDI-Public: 30382903835394
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383539
• Device Catalogue Number: 383539
• Device Lot Number: 1120097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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