MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number	383641
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
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.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.
Event or Problem Description
It was reported that bd nexiva w/ cap leaked.The following information was provided by the initial reporter, translated from dutch to english: leakage at split needle hose.27 nov was the device being used in/on patient when the issue occurred? yes.Was patient or user harmed? if yes, please explain no.Was the hcp present when the issue occurred? yes.If leakage occurred, please confirm the fluid that leaked.Nacl 0.9%.Was additional medical intervention/medication required? if yes, please explain.No.
Additional Manufacturer Narrative
Investigation results: the complaint of a leak was confirmed, and the cause appeared to be manufacturing related.One 24g nexiva iv catheter was received with evidence of use.A functional test revealed a leak from the iv catheter at the nose of the adapter.A microscopic examination of the iv catheter revealed damage to both the nose of the adapter and the catheter tubing.Due to the characteristics of the damage, the device was likely damaged during assembly.The appropriate 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 additional information.

• Brand Name: BD NEXIVA
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20874769
• Report Number: 2243072-2024-01205
• Device Sequence Number: 8688075
• Product Code: FOZ
• UDI-Device Identifier: 00382903836413
• UDI-Public: (01)00382903836413
• 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): 02/22/2025

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: Other
• Device Catalogue Number: 383641
• Device Lot Number: 3320157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown