MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20 GA X 1-3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Model Number	383518
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that nexiva 20 ga x 1-3/4 in single port had incorrect labeling.This was discovered before use.The following information was provided by the initial reporter: material no.383518, batch no.9325203.It was reported that package contained the wrong product, incorrect labeling.
Additional Manufacturer Narrative
H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 9325203, and no quality issues were found during production.Our quality engineer reviewed the provided photo but could not identify visible evidence that the product was contained inside the dispenser.The provided photo only showed the label information.Based off the provided photo the engineer was unable to verify the reported defect and without a physical sample available for investigation a definitive root cause could not be determined.
Event or Problem Description
It was reported that nexiva 20 ga x 1-3/4 in single port had incorrect labeling.This was discovered before use.The following information was provided by the initial reporter: material no.(b)(6).Batch no.9325203 it was reported that package contained the wrong product, incorrect labeling.

• Brand Name: NEXIVA 20 GA X 1-3/4 IN SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10451389
• Report Number: 1710034-2020-00533
• Device Sequence Number: 2591022
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: 30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 383518
• Device Catalogue Number: 383518
• Device Lot Number: 9325203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other