MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number	383518
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva tubing separated from hub.The following information was provided by the initial reporter: we also had a nexiva 20g catheter leak upon insertion.It separates at the wings of the device.I don't have anymore information on this; i was just given the device.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Event date updated to unknown in b tab.Product information updated in d tab.Investigation results: the complaint of a leak was confirmed, and the cause appeared to be manufacturing related.One 20g nexiva iv catheter was provided for investigation.A functional test revealed a leak at the junction of the extension tubing and the catheter adapter.The tubing remained bonded to the adapter; however, the adhesive bond between the tubing and the adapter appeared to be incomplete, which resulted in a leak path.The appropriate manufacturing personnel were notified of this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
Event date updated to unknown.

• Brand Name: BD NEXIVA
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21256882
• Report Number: 2243072-2025-00027
• Device Sequence Number: 12822802
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: (01)00382903835188(11)240201(17)270131(10)4031376
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 383518
• Device Lot Number: 4031376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown