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

Catalog Number	383540
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Recently received several vim reports regarding these infusion needles.(see photos attached) the caps leak when not extra tightened.This applies to both the cap that comes loose and the cap that is already connected.When we do not tighten the caps, they even fall off.Leakage occurs with all liquids when the caps are not additionally tightened.Potentially cause an emergency and that is of course not the intention.Incidentally, leakage occurs with all liquids when the caps are not additionally tightened.Cytostatics is only an example because of the highest risk.
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.
Additional Manufacturer Narrative
The complaint of leakage at the q-syte connector and vent plug could not be confirmed from the five photographs and nexiva devices that were provided for investigation.A visual examination revealed no damage or defects on the returned samples or photographs.The nexiva devices were received in sealed unit packages.The vent plug and q-syte connector were not loose.Although the representative samples, photographs, and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.Upon removing the nexiva device from the unit package, the instructions for use (ifu) state, "inspect device for damage before insertion.Ensure clamp is not engaged and vent plug and bd q-syte device are secure.Caution: do not use if device is damaged." after removing the vent plug, the ifu states, "securely attach bd q-syte device or end cap to luer adapter".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.

• 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: 24188999
• Report Number: 1710034-2026-00064
• Device Sequence Number: 9850819
• Product Code: FOZ
• UDI-Device Identifier: 00382903835409
• UDI-Public: (01)00382903835409(11)240321(17)270228(10)4081117
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 383540
• Device Lot Number: 4081117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown