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

Catalog Number 383642

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

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

Event Date 04/28/2022

Event Type  malfunction  

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 the safety mechanism failed to disengage while using the bd nexiva¿ closed iv cannula system.This event occurred 3 times.The following information was provided by the initial reporter: 3 cases of needle getting stuck in needle safety device and unable to be disconnected from the cannula.

Event Description

It was reported that the safety mechanism failed to disengage while using the bd nexiva¿ closed iv cannula system.This event occurred 3 times.The following information was provided by the initial reporter: 3 cases of needle getting stuck in needle safety device and unable to be disconnected from the cannula.

Manufacturer Narrative

Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displays a used 22gx1.00in single port nexiva device fully retracted and not decoupled from the wing adapter.The photo shows the device inserted in the patient's arm and the blood in the catheter extension.The reported issue was confirmed as the device failed to decouple.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD NEXIVA¿ CLOSED IV CANNULA 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: 14502930
• MDR Text Key: 292716020
• Report Number: 1710034-2022-00269
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383642
• Device Lot Number: 1140699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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