MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number 383512

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in was leaking.The following information was provided by the initial reporter: "when using nexiva sp and the intrafix primeline infusion set from b.Braun, the connection between these two products leaks during drug administration and the drug leaks at the connection point.After using nexiva sp and the intrafix primeline infusion set from b.Braun for drug administration, the infusion set very often cannot be twisted off from the extension part of the nexiva sp.Sometimes even using 2 pliers to open the connection does not help, in which case the catheter must be removed together with the infusion set.This issue has been observed also with different batches.".

Event Description

It was reported that bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in was leaking.The following information was provided by the initial reporter: "- when using nexiva sp and the intrafix primeline infusion set from b.Braun, the connection between these two products leaks during drug administration and the drug leaks at the connection point.- after using nexiva sp and the intrafix primeline infusion set from b.Braun for drug administration, the infusion set very often cannot be twisted off from the extension part of the nexiva sp.Sometimes even using 2 pliers to open the connection does not help, in which case the catheter must be removed together with the infusion set.This issue has been observed also with different batches.".

Manufacturer Narrative

Additional information d.10 device available for eval yes, returned to manufacturer on: 2020-02-24.H.6.Investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one 22ga nexiva and a braun device.Through the visual examination, damage was not observed on the nexiva device.The returned units were leak tested using a slip luer, a q-syte connection, and the braun device.Leakage was not observed in any of the systems.The nexiva and braun device separated easily after the leak test was completed.The returned nexiva unit provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9727740
• MDR Text Key: 188325884
• Report Number: 1710034-2020-00098
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 383512
• Device Catalogue Number: 383512
• Device Lot Number: 8334526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention