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

Catalog Number	383647
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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 hub broke the following information was provided by the initial reporter: nexiva broken at the hub when did the incident occur? during use nexiva leaked at the hub, by inspection there was a crack visible in the hub.There is no information at this moment of the therapy given over the nexiva, nor how long it was in use or if there has been any force on the hub.The customer didn't come back with any extra information at this point.(b)(6) 2025.Was patient or user harmed? if yes, please explain no.Was additional medical intervention/medication required? if yes, please explain no.
Additional Manufacturer Narrative
The complaint of a crack in the dual port luer adapter was confirmed; however, the root cause could not be determined.Two photographs were provided for investigation.Both photos show a crack in the dual port luer adapter.The sample exhibited evidence of use.As the device had been opened and used, it could not be determined with certainty whether the damage originated during manufacturing or in the clinical setting.The observable features on the submitted photographs did not contain enough information to identify a specific root cause of the reported event.No information was provided regarding the duration of use or the affected lot number.Complaints received for this device and reported condition will continue to be tracked and trended as part of ongoing efforts to identify potential manufacturing related issues.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.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
• 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: 22690117
• Report Number: 1710034-2025-01276
• Device Sequence Number: 15530464
• Product Code: FOZ
• UDI-Device Identifier: 00382903836475
• UDI-Public: (01)00382903836475
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 383647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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