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

Catalog Number	383556
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This occurred on (b)(6) 2025.We had another instance of blood leaking from the end of the iv catheter on product 383556.This caused the patient to be stuck a second time.
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.
Additional Manufacturer Narrative
The complaint of blood leaking from the iv catheter was confirmed; however, the root cause could not be determined.One photograph of a 20ga nexiva iv catheter was provided for investigation.The sample exhibited evidence of use, and the needle had been removed from the catheter.What appeared to be blood residue was visible on the external surface of the catheter adapter near the septum.Fluid can leak from this location if the septum is misaligned or damaged.While the septum condition could not be determined from the image, a trend for leaks at this location indicates that the cause of the reported issue could be manufacturing related.Without the physical sample, the root cause of the reported issue could not be determined.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: 22853244
• Report Number: 1710034-2025-01389
• Device Sequence Number: 15567723
• Product Code: FOZ
• UDI-Device Identifier: 00382903835560
• UDI-Public: (01)00382903835560
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: 383556
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/22/2025
• 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