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

Catalog Number	383559
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/31/2025
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
One of the ports on this iv came off during the iv insertion and the rn was splashed in the eye by blood.
Additional Manufacturer Narrative
The complaint that the extension tubing disconnected from the luer adapter was confirmed and the cause appeared to be manufacturing related.One 18g nexiva iv catheter was provided for investigation.The green luer adapter was not returned with the iv catheter.The sample exhibited evidence of use.Blood residue was observed throughout the catheter tubing and extension tubing.No evidence of adhesive was observed on the end of the extension tube that was attached to the green luer adapter.No evidence of elastic weakness was observed in the extension tubing that would suggest that the material was stretched.Although the complete sample was not returned for investigation, the separation of the luer adapter was likely manufacturing related.Leakage would have been a result of the separation.There were no other similar complaints associated with the implicated lot.The 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.
Event or Problem Description
No new information.

• Brand Name: NEXIVA MAXZERO
• 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: 23619735
• Report Number: 1710034-2025-01850
• Device Sequence Number: 9032235
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: (01)00382903835591(11)240827(17)270731(10)4240166
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 383559
• Device Lot Number: 4240166
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown