MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383539

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/30/2018

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 during use a bd nexiva closed iv catheter system malfunctioned as "the needle broke off." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

Event Description

It was reported that during use a bd nexiva closed iv catheter system malfunctioned as "the needle broke off." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Level b mdr investigation: dhr review - the dhr was reviewed and no issues were identified during production.Qn review - no qns were initiated relating to the defect during production.Eura review - a cause of the defect, that was confirmed during the investigation into other complaints, is a missing feature on the needle.A situation analysis was initiated to further investigate and address the issue.Sample analysis - sample revealed that the needle pulled through the tip shield and that it had no bump.Investigation conclusion: the cause of the defect was a missing feature on the needle that keeps the tip of the needle in the tip shield.A capa initiation determination is being executed to determine the need for a capa.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system malfunctioned as "the needle broke off." there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7601130
• MDR Text Key: 111491921
• Report Number: 1710034-2018-00351
• 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,Followup
• Report Date: 09/19/2018

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: 05/30/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 05/30/2018; 05/30/2018
• Supplement Dates FDA Received: 08/09/2018; 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other