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

Catalog Number 383539

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 06/12/2018

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 that there was a safety shield activation failure while using a bd nexiva¿ closed iv catheter system safety device.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Observations and testing could not be performed because units were not provided for investigation.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.The lot number 8087800 is currently being investigated further for review of the safety shield activation failure.Investigation conclusion: the root cause was related to manufacturing.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.Capa #(b)(4) has been opened to address this incident.Capa (b)(4) problem statement: the tip shield did not properly capture the tip of some nexiva 18 ga needle between the v-clip and washer.Instead, due to the failure mode of bump out of specification (small or missing), the needle pulled through the washer and allowed the gray tip shield to disconnect from the needle assembly.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacturer: no.

Event Description

It was reported that there was a safety shield activation failure while using a bd nexiva¿ closed iv catheter system safety device.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: 7659616
• MDR Text Key: 113284043
• Report Number: 1710034-2018-00377
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• 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