MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVENOUS CATHETER

Catalog Number 383556

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/29/2017

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 during use of the 20 g x 1 in.Bd nexiva¿ closed iv catheter system when rns have drawn blood the small plastic piece in the hub has come unattached.After the iv is in place, blood is coming out of the tubing unexpectedly.Blood splashed towards a nurse with an hiv infected patient.There was no report of injury or medical intervention.

Manufacturer Narrative

Correction of awareness date, from (b)(6) 2017.

Manufacturer Narrative

Investigation: a review of the provided sample revealed that the vent plug was loose within the sealed packaging.This incident is manufacturing related and action has been taken to notify the appropriate personnel.During the device component evaluation was confirmed that all defect mentioned in the record have a relation between them, if the vent plug is not attached to the hub of the extension set, the user can be exposure to a blood coming out of extension set tubing considering this like a leakage in the extension set.A review of the device history and manufacturing records revealed no irregularities during the manufacture of the reported lot #.This defect can be caused during the normal shipping of product or handling of the product.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time,.

• Brand Name: 20 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6966806
• MDR Text Key: 90752523
• Report Number: 1710034-2017-00277
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835561
• UDI-Public: 30382903835561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2017

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: Nurse
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 383556
• Device Lot Number: 7075739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 04/06/2017; 04/06/2017
• Supplement Dates FDA Received: 11/10/2017; 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other