MAUDE Adverse Event Report: BECTON DICKINSON SANDY BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problems Decoupling (1145); Leak/Splash (1354)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced a q-syte separation.The following information was provided by the initial reporter: i have tested myself with the infusion line and the blue 22ga needle, in doing so the line does indeed detach from the nexiva (coupling between infusion line & q-syte).Did the defect lead to a leak? yes, after the line detaches, the fluid leaks onto the floor instead of into the patient.

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

The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 14-jul-2022.H.6.Investigation summary: bd received an unsealed 22ga x 1.00 in.Nexiva unit from lot 0339494.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit but did not discover any damage to the q-syte, adapter, or the cross threading.A syringe with water was attached to the q-syte and pushed through the unit to determine if there was any leakage or connection issue.The connector provided by the user was also used to try to replicate the issue.However, no issues were discovered during testing.Therefore, the engineer was unable to verify the reported defect.Since no defects could be identified during inspection a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system experienced a q-syte separation.The following information was provided by the initial reporter: i have tested myself with the infusion line and the blue 22ga needle, in doing so the line does indeed detach from the nexiva (coupling between infusion line & q-syte).- did the defect lead to a leak? yes, after the line detaches, the fluid leaks onto the floor instead of into the patient.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON SANDY; 9450 s state st; 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: 14855737
• MDR Text Key: 296151215
• Report Number: 1710034-2022-00328
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: 00382903835324
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K183399
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 383532
• Device Lot Number: 0339494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• 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