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

Catalog Number	383556
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the nurse had to remove the catheter because she couldn't get it into the patient's vein.The needle pierced the polyurethane cannula.The nurse said that she did not reinsert the needle into the catheter when it was inserted into the patient's vein.When did the incident occur? during use the needle went through the catheter.Additional info received on 2-6-2026 7:23 pm.Adverse effects (note the exact terms used by the notifier): when we insert the needle into the vein, the catheter goes off course and bends, making it impossible to insert the catheter.Observed clinical consequences: patients' veins giving way.
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
No new information.
Additional Manufacturer Narrative
The complaint of the needle puncturing the catheter was confirmed and the cause appeared to be associated with use.One photograph was provided for investigation, which showed two 20g nexiva devices.On one sample, a needle was protruding through the nexiva iv catheter tubing.Due to the presence of what appeared to be blood residue between the catheter tip and the needle puncture site, it appeared that the catheter was able to access the vessel, which indicates that the needle likely punctured the tubing after insertion.Both catheters exhibited a bend in the catheter tubing, which is consistent with needle puncture damage.The catheter with the needle was bent at the needle puncture site.Both samples exhibited evidence of use.Without the physical samples, it could not be confirmed that both samples were punctured.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur." no defects associated with the manufacturing process could be identified from the photograph.Manufacturing controls are in place to mitigate the occurrence of this type of failure.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.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.

• 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: 24293520
• Report Number: 1710034-2026-00119
• Device Sequence Number: 18474843
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577(10)UNKNWON
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 383556
• Device Lot Number: 5043986
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown