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

Catalog Number 383539

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

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 with the use of the bd nexiva¿ closed iv catheter system there was an issue with the safety mechanism failing.It was stated ¿the safety end which sheaths the needle falls off when deploying leaving the needle exposed.We¿ve done random tests and only this lot number has the problem.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: no sample available for investigation.Dhr record review findings: the lot was manufactured on nexiva line 1 from 29mar18 through 4apr18.All challenges were successful set-up and in process samples including (but not limited to) machine caused damaged were performed at various stages during the manufacturing process and all passed per specification.During the investigation of other similar complaints, this defect as stated in the event description has been confirmed on this batch.The lot number associated with this incident is under global qn (b)(4) for safety shield activation failure.The root cause and corrective actions are currently being investigated by the correspondent team.This incident is currently being investigated through a voluntary recall including field action, mps-18-1293- fa.Corrective action project / capa (#505083): this is an issue with the safety feature of the device.Although occurrence is low and all reported incidents thus far have limited severity (contaminated needle stick injury with no known blood borne pathogen), there is the potential for higher severity end user effects.A capa project has been opened to address this incident.

Event Description

It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with the safety mechanism failing.It was stated ¿the safety end which sheaths the needle falls off when deploying leaving the needle exposed.We¿ve done random tests and only this lot number has the problem.¿ there was no report of injury or further medical intervention.

• 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: 7620692
• MDR Text Key: 112062080
• Report Number: 1710034-2018-00359
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835394
• UDI-Public: 30382903835394
• Combination Product (y/n): N
• PMA/PMN Number: K111366
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 383539
• Device Lot Number: 8087800
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other