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 06/12/2018

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 the push tab fell off a bd nexiva¿ closed iv catheter system after insertion.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

No sample available for investigation.Photograph was provided for investigation.Photographs displayed 2 actual samples.One device for (b)(4) and the other for (b)(4).Device/batch history 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.Although units were not returned; a photo was provided for observation of this incident which revealed the following: there was a top web (tyvek lid) from a package from lot 8087800.There were two units of which both revealed to have had the needle pull through the tip shield.There were traces red fluid in area through one unit and traces of media present in areas throughout the second unit.Confirmed that both units in the photo demonstrated that the tip shield did not safeguard against an accidental needle stick.Root cause: relationship of device to the reported incident is manufacturing.Comment: the lot number associated with this incident is under global (b)(4) for safety shield activation failure.The root cause and corrective actions are currently being investigated by the correspondent team.(b)(4).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 that the push tab fell off a bd nexiva¿ closed iv catheter system after insertion.There was no report of exposure, injury, or 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: 7636530
• MDR Text Key: 112436448
• Report Number: 1710034-2018-00371
• 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

• Date FDA Received: 06/25/2018
• 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
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other