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

Catalog Number	383519
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva single port leaked at the septum.The following information was provided by the initial reporter: we had incidents that the back-end portion of these iv catheters were leaking and causing patient safety issue.Customer response on 28-apr-2025.1.Can you please provide an exact date of event in format mm-dd-yyyy? i can't remember when the actual dates were all six cases were in the last 4 weeks.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.In every case because the back end of the catheter was leaking so the catheter had to be removed and replaced requiring the patient to have to get poked with another needle to have a patient iv access.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complain of a leak at the septum was confirmed and the cause appeared to be manufacturing related.Two photographs and three 18g nexiva units were provided for investigation.What appeared to be blood residue was present between the grey canister and the catheter adapter, which was indicative of leakage.The septum was deformed, which suggests that the septum was misaligned at the time of assembly within the catheter adapter.The damage appeared to be manufacturing related and the appropriate manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• 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: 21969922
• Report Number: 1710034-2025-00754
• Device Sequence Number: 8492616
• Product Code: FOZ
• UDI-Device Identifier: 00382903835195
• UDI-Public: (01)00382903835195(11)240822(17)270731(10)4235516
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: Health Professional
• Device Catalogue Number: 383519
• Device Lot Number: 4235516
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown