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

Model Number 383519

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 prior to use it was discovered that the expiration date was not printed on the box with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: exp.Date wasn't printed on the box.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received five photographs.One photograph displayed the lot number, expiration date and bar code were missing from the dispenser label.The reported issue was confirmed.This was physical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error during the inspection process.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that prior to use it was discovered that the expiration date was not printed on the box with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter, translated from japanese to english: exp.Date wasn't printed on the box.

• 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: 9431361
• MDR Text Key: 178321025
• Report Number: 1710034-2019-01298
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835196
• UDI-Public: 30382903835196
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 383519
• Device Catalogue Number: 383519
• Device Lot Number: 9032758
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other