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

Catalog Number	383552
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E and f codes updated.Investigation results: the complaint that the catheter broke or separated from the catheter hub during use could not be confirmed from the photograph or representative samples that were provided for investigation.One photograph and 17 representative 22g nexiva iv catheter were provided for investigation.The photo showed a 22g nexiva iv catheter.The majority of the catheter tubing was shown separate from the catheter adapter.A short segment of tubing appeared to be present over the wedge within the catheter adapter.The vent plug was positioned within the blue luer adapter, which indicates that the iv catheter was not used.The device shown in the photo was likely the sample that was intentionally pulled to replicate the problem.Since it is unknown at what lbf the catheter in the photo separated at, no investigation conclusion could be made from the sample photo.The device from the photo and the affected unit were not returned for investigation.Seventeen representative samples were provided for investigation.A catheter pull test was conducted, which showed that the representative samples were within specification.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The reported issue was inclusive and the root cause could not be determined from the photograph or representative samples.There were no other similar complaints from the implicated lot.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.
Event or Problem Description
No new information.
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.
Event or Problem Description
For the d2 incident it occurred around on (b)(6) 2026 and when the rn went to remove the piv because it was not patent, they noticed the tip looked like it was cut.It was confirmed from xxx there was a ¿3.2mm foreign body or catheter fragment within the forearm cephalic vein which is thrombosed.¿ vascular saw this patient on (b)(6) 2026 and stated no surgical intervention, might intervene if patient becomes symptomatic.Additional information 4/22/2026: rt arm venogram and rt arm and chest ct were reviewed by two radiologists thoroughly and no foreign object was seen.Patient was discharged.

• 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: 25020954
• Report Number: 1710034-2026-00477
• Device Sequence Number: 18757642
• Product Code: FOZ
• UDI-Device Identifier: 00382903835522
• UDI-Public: (01)00382903835522(11)251125(17)281130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 383552
• Device Lot Number: 5329059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown