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

Catalog Number	383519
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Discomfort (2330); Insufficient Information (4580)
Date of Event	05/11/2025
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.
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: date of incident: (b)(6) 2025.Level of harm: minimal harm.Incident details: after withdrawing iv initiation needle into the safety device, there was a sudden back flow of blood out of port where needle is pulled back through.Impact of incident: delay to treatment/therapy.Who was affected? patient.
Event or Problem Description
On (b)(6) 2025 yes, a different iv needed to be initiated cause a delay and increase in patient discomfort as they required two pokes when 1 should suffice.
Additional Manufacturer Narrative
Patient outcome clarification received from the customer.Annex e/f codes updated.
Additional Manufacturer Narrative
Unfortunately, a lot number could not be submitted for this complaint and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally, one unsealed nexiva unit was received for investigation.The returned components included one catheter assembly and two needle shields.The units appeared to have been used, and blood was observed at the back of the septum.The reported nonconformance has been confirmed.Microscopic analysis revealed that the septum was not properly seated, which likely created a gap between the components, which allowed for the seepage of fluids.The most likely root cause for this event is related to a misalignment of the automated assembly station, during the manufacturing process, to prevent future occurrences of this event a notification has been issued to the appropriate manufacturing personnel.
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: 22130999
• Report Number: 1710034-2025-00931
• Device Sequence Number: 7343023
• Product Code: FOZ
• UDI-Device Identifier: 00382903835195
• UDI-Public: (01)00382903835195
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided; 07/23/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/23/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown