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

Catalog Number 383512

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2018

Event Type  malfunction  

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.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system malfunctioned as ¿the needle does not separate from the catheter.¿ there was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Per review of the dhr it was concluded that all required challenge samples and testing was performed per specifications, in accordance with the in-process sampling plans.Review disclosed there was no indication of the alleged defect as there was one non-related qn initiated and no reject activity findings throughout the build of this lot that would impact upon the quality of the product relevant to the defect stated in the pir.Observations and testing could not be performed because units were not provided for investigation.Confirmation of the defect as stated in the product incident report, could not be identified or confirmed and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.This incident is indeterminate.Relationship of device to the reported incident: indeterminate the defect described in the product incident report was not confirmed or replicated; as units were not provided for this incident, therefore a definite root cause could not be established.

• 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: 7322717
• MDR Text Key: 101975961
• Report Number: 1710034-2018-00083
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: 30382903835127
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 383512
• Device Lot Number: 7013542
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other