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

Model Number 383532

Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced an incorrect colored device and leakage. The following information was provided by the initial reporter. The customer stated: the nurse write this: i need to apply blue pvk to a patient who needs an infusion. When i unpack the package on the blue pvk 22 g, the butterfly is blue, but the one where you rinse through with nacl is pink where it is normally blue? i make sure it's the right lumen on the needle and that's it. That's why i use the pvc. It works fine to install the pvc, which returns blood in the hose and i close at the clamping screw. When i have to rinse with saline i open the clamping screw and blood comes out where the pink piece should be stuck on the hose and when i try to rinse in, saline comes out of the pink piece but not into the hose. Therefore, the pvc is discontinued and a new one must be placed.

Manufacturer Narrative

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

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12783376
• MDR Text Key: 285320741
• Report Number: 1710034-2021-00967
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 12/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 383532
• Device Catalogue Number: 383532
• Device Lot Number: 1119321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial