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

Catalog Number	383556
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K183399; k243403.Customer has not responded to follow up requesting clarification if catheter tip retention occurred, if diagnostics were done, or medal treatment/procedure was required.Conservatively filing as a serious injury based on the presumed foreign body retention, but it is not clear if this occurred.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
It was reported that the catheter separated or broke from the hub.Patient received 20g nexiva for ct scan with contrast.Ct tech tested the line with saline, line was patent to administered the contrast.The nexiva/ scan did not pressure out however the extension tubing expanded and doubled in size.When catheter was removed from patient, the catheter tip is missing.Patient outcome: unsure at this time, unable to locate catheter tip.
Additional Manufacturer Narrative
The complaint that the extension tubing expanded was confirmed; however, the root cause could not be determined.Three used 20g nexiva iv catheters and thirteen unused representative samples (3 sealed samples from lot 5329073, 2 sealed samples from lot 5199823, and 8 sealed samples from lot 5343136) were provided for investigation.The batches from the representative samples were not part of your initial report.We have attempted to reach out to you to identify which were involved in the reported event, but no response was received.It was confirmed from the used samples that the extension tubing was ballooned.No defects or occlusions associated with the manufacturing process were identified on the affected units.One of the used device was received with the catheter tubing cut and the severed end of the catheter was not provided for investigation.Evidence observed on the tubing indicated that the tubing was cut with a sharp instrument.Due to the evidence of use, the catheter may have been cut intentionally after use.No damage or defects were identified on the sealed representative samples that were provided for investigation.By intentionally clamping the iv catheter, the ballooned tubing was replicated with an unused device.The instructions for use (ifu) state, "ensure catheter patency according to your facility policy immediately before power injection.Warning: failure to ensure patency of the catheter may result in catheter failure and or extravasation.Avoid kinking or obstructing catheter during power injection.Warning: in the event of an occlusion, power injector pressure-limiting features may not prevent catheter failure." the ifu also states, "the 22-18 ga (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kpa) when access ports not suitable for use with power injectors are removed." 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.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 trend.
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: 24766957
• Report Number: 1710034-2026-00364
• Device Sequence Number: 21156883
• Product Code: FOZ
• UDI-Device Identifier: 00382903835560
• UDI-Public: (01)00382903835560
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 383556
• Device Lot Number: UNKNOWN
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown