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

Catalog Number	383531
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: the complaint of damaged luer adapters was confirmed and the cause appeared to be manufacturing related.Two 24g nexiva devices were provided for investigation.On one sample, the straight adapter exhibited deformation from being compressed.The yellow adapter material was pushed inward, which caused the luer taper to deform inside the adapter.The deformation prevented a seal between the q-syte connector and the adapter.On the other sample.The threads on the y-adapter were damaged and the deformation was not consistent with overtightening.In both instances, the damage and deformation appeared to be manufacturing related.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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
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 threading treading faulty.The following information was provided by the initial reporter: situation: issue: the iv set was faulty, leaking at the mainline port.Tightening caps did not work because the threading was faulty.Iv had to be removed and pt had to be stuck again for iv insertion.Background: event date: 12/6/2024.Ih #: 80011227.Mfg #: 383531.Description: cath iv nexiva 24gax.075 383531.Sample available: yes (if sample is available and would like it sent for your evaluation, please reply all, and attach a return shipping label via email) lot #: 4178005.Assessment: credit requested: no.Po # 82528.Was there injury? no.Name of facility: xxx.Main contact name and email address: xxx.Frontline caregivers contact information (if applicable): na.Account # po purchased on: (b)(4).

• Brand Name: BD 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: 21067949
• Report Number: 1710034-2024-01573
• Device Sequence Number: 3418254
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317(11)240626(17)270630(10)4178005
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 383531
• Device Lot Number: 4178005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown