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

Catalog Number	383539
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
18ga iv catheter looks to have a hole near the clamp and when iv was being given proceeded to leak blood out from the hole.
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.
Additional Manufacturer Narrative
The complaint of a breach in the extension tubing and leak was confirmed; however, the root cause could not be determined.One 18g nexiva iv catheter was returned for investigation.The sample exhibited evidence of use.A circumferential breach was observed in the extension tubing, which allowed fluid to leak.As the device had been opened and used, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.Complaints received for this device and reported condition will continue to be tracked and trended.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
(b)(6) 2025.There was no injury, but the patient did require a re-stick for another iv site (both times), and we use 18-gauge iv catheters, which can be uncomfortable for insertion.Additionally, with a well-functioning iv site and a large gauge, there was a significant amount of blood flowing due to a defect in the tubing, which unnecessarily exposed the staff member to a considerable volume of blood.The patient had no serious injury and had a working iv site for her induction of labor for the day.The nurse did not have any direct contact with blood other to her gloved hands and scrubs which she was able to change.

• 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: 23432193
• Report Number: 1710034-2025-01698
• Device Sequence Number: 8252914
• Product Code: FOZ
• UDI-Device Identifier: 00382903835393
• UDI-Public: (01)00382903835393(11)250529(17)280531(10)5148487
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 383539
• Device Lot Number: 5148487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown