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

Model Number 383511

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one used catheter assembly with a syringe and one photo.Upon inspection of the received device, it was identified that the syringe connected to the luer port could not be drawn indicating an occlusion was present.Your reported defect was confirmed.Upon visual inspection of the luer port, it was found that at the base of the luer the tubing was occluded by adhesive.This defect most likely occurred at the dispense adhesive station when the adhesive was being applied to the outside of the tubing.Preventative maintenance and quality inspections are performed at regular intervals to mitigate the risk from this type of defect.A device history record review showed no non-conformance's associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.Information will be captured on trend reports and monitored.We regret any inconveniences this incident may have caused you and your facility.

Event Description

It was reported when using the bd nexiva¿ closed iv catheter system, the device experienced foreign matter on the device cannula/needle / catheter.This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: when the indwelling needle was connected with prefilled flusher, it couldn't push the plunger to exhaust.

• 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
• MDR Report Key: 12540824
• MDR Text Key: 273609994
• Report Number: 1710034-2021-00847
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 383511
• Device Catalogue Number: 383511
• Device Lot Number: 0295533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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