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

Catalog Number	383559
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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 sp with maxzero leaked at the septum.The following information was provided by the initial reporter: when they administered the needle into the patient, blood from the patient started coming out of the grey capped part on the port.This caused them to have to remove the needle, and try again with a different one, and it ended up being fine additional info: there were no serious events that happened from this incident, the needle was simply removed, and a new one was used on the patient.
Additional Manufacturer Narrative
The complaint of a leak from the septum could not be confirmed from the photographs that were provided for investigation.The photos showed a unit label and an 18g nexiva device with evidence of use.The needle had been removed from the catheter adapter, but no blood could be seen at or around the septum.No defects associated with the manufacturing process could be confirmed from the photos.Although the photographs and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.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: 22560713
• Report Number: 1710034-2025-01214
• Device Sequence Number: 9528733
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: (01)00382903835591(11)240830(17)270831(10)4242230
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 383559
• Device Lot Number: 4242230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown