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

Catalog Number	383556
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 catheter was still in the patient¿s arm, i was drawing blood and knew it was bad because it was bubbling so i went to take it out and it did this¿ (photo depicts catheter separated from hub).She told me two other nurses had issues with 20g ivs earlier in the day and said it appeared that there was a hole in the top and the catheter was not connected to the hub well.I did instruct staff to go ahead and pull any ivs with the same lot number.They were able to get catheter out of patient arm.
Additional Manufacturer Narrative
The complaint of damaged tubing was confirmed, but the root cause could not be determined from the 20g nexiva iv catheter that was provided for investigation.A longitudinal split was identified in the extension tubing.Due to the evidence of use, it is possible that the tubing ruptured from over pressurization; however, the root cause could not be determined.The instructions for use (ifu) provide instructions, warnings, and settings for power injection equipment to prevent catheter failure.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.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 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: 23433354
• Report Number: 1710034-2025-01706
• Device Sequence Number: 15586826
• Product Code: FOZ
• UDI-Device Identifier: 00382903835560
• UDI-Public: (01)00382903835560(11)250626(17)280630(10)5177487
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 383556
• Device Lot Number: 5177487
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown