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

Catalog Number 383512

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2018

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 before opening the bd nexiva¿ closed iv catheter system packaging, the filter was detached from the hub.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: device/batch history record review was performed on the lot number 7307925.The lot number was built on nfa #2, from november 6, 2017 thru november 11, 2017.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.End user risk analysis (eura) review was analyzed to determine potential production causes and to assess the risk to customer.A potential cause of ¿detached flow vent plug¿ is ¿improper setup¿ during production.From the review of the dhr, no issues were identified.The occurrence of this incident does not exceed what is considered acceptable.Received one unused nexiva 22g unit in opened package from the lot number 7307925.Visual/microscopic examination: the vent plug was loose inside of the opened package.There was no definite evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident as the package was returned opened.Per the ifus in section; catheter insertion: - inspect the catheter system.Check that the clamp (5) is not engaged and that the vent plug (7) and bd q-syte device (8) are secure.Do not over tighten.The severity of this incident is negligible and the occurrence is low.Therefore no formal corrective action is necessary at this time.

Event Description

It was reported that before opening the bd nexiva¿ closed iv catheter system packaging, the filter was detached from the hub.Found before use.No reports of serious injury or medical intervention noted.

• 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: 7551026
• MDR Text Key: 109573555
• Report Number: 1710034-2018-00242
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: 00382903835126
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 383512
• Device Lot Number: 7307925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other