MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR CATHETER

Model Number	383579
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector was missing the tubing clamp.The following information was provided by the initial reporter: "manufactured without standard white clamp on tubing".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
After further review, this report was found to be a duplicate report.Therefore, this mdr will be cancelled.
Event or Problem Description
It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector was missing the tubing clamp.The following information was provided by the initial reporter: "manufactured without standard white clamp on tubing".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR
• Common Device Name: INTRAVASCULAR CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16755941
• Report Number: 1710034-2023-00421
• Device Sequence Number: 15610094
• Product Code: FOZ
• UDI-Device Identifier: 00382903835799
• UDI-Public: 00382903835799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: Other
• Device Expiration Date: 06/30/2025
• Device Model Number: 383579
• Device Catalogue Number: 383579
• Device Lot Number: 2186277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown