MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN; INTRAVASCULAR CATHETER

Model Number 383517

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the bd nexiva¿ closed iv catheter system ¿ single port 20 ga 1.25 in experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: label which exp.Date should be written was missing on the shelf carton.

Manufacturer Narrative

H.6.Investigation summary bd received two photographs which displayed the label on the product box was missing.This was physical/mechanical 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system ¿ single port 20 ga 1.25 in experienced no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: label which exp.Date should be written was missing on the shelf carton.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9775237
• MDR Text Key: 185294796
• Report Number: 1710034-2020-00126
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• 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: 04/10/2020

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: 08/31/2022
• Device Model Number: 383517
• Device Catalogue Number: 383517
• Device Lot Number: 9255007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other