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

Catalog Number	383537
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 nexiva broken at the hub response received on: 1/13/2026.The nexiva malfunctioned while it was in situ in one of the patient's veins.The patients are not injured, but since it was determined that the nexiva was defective, medication is being administered intravenously.
Additional Manufacturer Narrative
Customer provided material number.Information updated.
Event or Problem Description
Material number provided.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a damaged dual port luer adapter was confirmed and the cause appeared to be manufacturing related.Photographs and one 18g nexiva iv catheter were provided for investigation.The sample exhibited evidence of use.A longitudinal crack was identified on one of the green luer adapters.The cause may have been a combination of various circumstances; however, manufacturing was likely a contributing factor.The appropriate manufacturing personnel were notified of this complaint.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
• 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: 24124173
• Report Number: 1710034-2026-00023
• Device Sequence Number: 18566322
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

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: 383537
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided; 02/04/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/23/2026; 02/04/2026
• 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
• Patient Sex: Unknown