MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT; PERIPHERAL IV CATHETERS

Catalog Number	383520
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
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.E1.Address information was not provided, therefore, (b)(6) was used as a place holder.
Event or Problem Description
It was reported that bd nexiva hf single port leaks at the septum.The following information was provided by the initial reporter: nexiva leaking from septum where the needle comes out.It has happened 4 times so far.(b)(6) could you please provide a further description of the issue? blood was leaking out of the grey septum where the needle comes out to safety.This happened 4 different times with different size gage and length catheters.When was this defect observed? during or before use? during use.What was the impact to the patient? had to get a new line.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no available sample.What was the fluid at use? n/a, blood leaking upon placement.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383520 and lot number 2312135.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA SINGLE PORT
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• 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: 20649045
• Report Number: 1710034-2024-01304
• Device Sequence Number: 18382869
• Product Code: FOZ
• UDI-Device Identifier: 00382903835201
• UDI-Public: (01)00382903835201(11)221108(17)251031(10)2312135
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 383520
• Device Lot Number: 2312135
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/10/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown