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

Catalog Number	383512
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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
The doctor reported that the hub of the nexiva device cracked during flushing after insertion.
Additional Manufacturer Narrative
The complaint of a crack in the single port luer adapter was confirmed; however, the root cause could not be determined.One photograph was provided for investigation.The photo shows a crack in the single port luer adapter while a slip fit syringe was attached.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 other similar complaints were reported from the implicated lot.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: 23421048
• Report Number: 1710034-2025-01686
• Device Sequence Number: 9863405
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: (01)00382903835126(11)241022(17)270930(10)4296512
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 383512
• Device Lot Number: 4296512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown