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

Catalog Number	383559
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When did the incident occur? during use blood flowed from the septum when the mandrel was removed it was reported that after the nurse inserted the catheter and removed the guidewire; blood began flowing from the septum and wouldn't stop.We had to remove the catheter.Material failure observed on (b)(6) 2026 on a nexiva 18g catheter during insertion in a patient with precarious venous capital.Procedure: slight mobilization of the canula before insertion of the kt (to check that it is working properly and to unstick the needle from the silicone which allows it to be cleaned on removal).Insertion of the flexible catheter into the extension of the canula removal of tourniquet.Removal of the canula with the safety system continuous bleeding at the base of the wings.In the end: the catheter had to be removed, and one of the patient's few accessible veins was damaged.
Additional Manufacturer Narrative
G.4.K183399; k243403 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 leak at the septum could not be confirmed from the four photographs that were provided for investigation.The photos showed an 18g nexiva device during a simulated insertion with the needle and catheter inserted through what appeared to be the top web of the unit package.The device shown in the photographs showed no evidence of use (e.G., no blood residue or fluid present within the extension tubing, catheter hub, or near the septum).Customer-applied markings (red and black pen marks) are present on the photographs to indicate the alleged fluid path, including filling of the extension tubing and leakage at the septum; however, the reported condition of blood leaking from the septum was not directly observable in the images.No visible damage, deformation, or abnormalities were identified at the septum, catheter hub, or associated components.The device configuration shown (including separation of components and positioning outside of typical use conditions) suggests a staged or simulated setup.It cannot be confirmed that the device shown represents the actual affected unit.The affected unit was not returned for physical evaluation.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
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: 25201463
• Report Number: 1710034-2026-00530
• Device Sequence Number: 18650889
• Product Code: FOZ
• UDI-Device Identifier: 00382903835591
• UDI-Public: (01)00382903835591
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 383559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown