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

Catalog Number	383532
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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.

• 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: 25626466
• Report Number: 1710034-2026-00717
• Device Sequence Number: 9011688
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: (01)00382903835324
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2026

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: 383532
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 06/28/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 06/29/2026
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White