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

Catalog Number	383551
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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 tubing damage with leak.The following information was provided by the initial reporter: hole in extension set on nexiva.Fluid coming through when pushing needed to dc line and start new iv.I submitted 2 complaints and mailed in 2 devices, however, we have at least 5 different patient safety events involving 4 patients.Not sure of the specifics of each, but 2 of the patients required additional sticks to replace the defective device.We have asked our staff to report any leaking, complete a safety event.I have not heard of any in the couple of days but i also don¿t see all the safety events.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a leak in the extension tube was confirmed; however, the root cause could not be determined.One video was provided for investigation, which showed a 24g nexiva iv catheter being flushed while it was inserted in a patient.The lot number of the device could not be determined from the video.A clear liquid was leaking from the point where the extension tube is bonded to the yellow luer adapter.The characteristics of the leak path could not be analyzed from the video.This type of damage may occur during manufacturing, if the extension tubing is partially inserted in the adapter or if there is inadequate adhesive.As the unit appears to have been used, the leak may have developed over time.Kinking of the extension tubing in the user environment may cause the tubing to fatigue and crack, resulting in damage that would allow fluid to leak.Without the physical sample, the root cause cannot be determined with certainty.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.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.

• 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: 22636729
• Report Number: 1710034-2025-01238
• Device Sequence Number: 9166818
• Product Code: FOZ
• UDI-Device Identifier: 00382903835515
• UDI-Public: (01)00382903835515(11)250103(17)271231(10)5003769
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 383551
• Device Lot Number: 5003769
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown