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

Catalog Number	383536
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
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
It was reported that bd nexiva leaked.Additional information received on (b)(6) 2026.When you state that ¿when the contrast was injected on one side, it came out the other,¿ is the contrast coming out of the section where the needle is removed from the winged connector, from the second end of the dual-port adapter at the tip of the extension tube, or from some other part of the device? additional information received on (b)(6) 2026 in response to your request, we would like to inform you that there was no harm to the patients involved in the events reported.During the events, it was only observed that the patients were wetted by the contrast resulting from the leak identified.There were no injuries, clinical complications or need for additional medical intervention.As an immediate corrective measure, the contrast was only reapplied so that the exams could be completed properly, without any further impact on the patients.

• 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: 25627869
• Report Number: 1710034-2026-00719
• Device Sequence Number: 12229009
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362(11)250501(17)280430(10)5120890
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 383536
• Device Lot Number: 5120890
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown