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

Catalog Number 383517

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/24/2018

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 with the use of the bd nexiva¿ closed iv catheter system there was an issue with sterility.It was stated ¿the package has black stripes and the item was not sealed properly.¿ there was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with sterility.It was stated ¿the package has black stripes and the item was not sealed properly.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: two unused units were returned from the customer in support of this complaint.The reported defect was observed.Dhr review - no related issues were identified during the production of the batch.Eura review - the presence of splice tape on the packaging was identified as a risk.The occurrence of this incident does not exceed what is considered acceptable.Investigation conclusion: the cause of the defect was splice tape on the product.The cause of splice tape making it through the inspections in the process is indeterminate.

• 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: 7495349
• MDR Text Key: 107709960
• Report Number: 1710034-2018-00203
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 383517
• Device Lot Number: 7214627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other