MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number	383530
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system the seal was compromised.This occurred 72 times.There was no report of patient impact.The following information was provided by the initial reporter: found 72 damage packages of nexiva dual port 0.56" so customers concerned about sterility and contamination.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system the seal was compromised.This occurred 72 times.There was no report of patient impact.The following information was provided by the initial reporter: found 72 damage packages of nexiva dual port 0.56" so customers concerned about sterility and contamination.
Additional Manufacturer Narrative
H6: investigation summary: a physical sample was not available for investigation but bd was provided with three photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 2182100, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed that the flanges of the bottom portion of the packaging appeared curled and the right tray was warped.The rigid packaging material was deformed and appeared to have a reduction in the width of the seal in one are of the sterile barrier.Therefore, based off the provided photos the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for inspection a definitive root cause could not be determined.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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 ; 8015296192
• MDR Report Key: 15965532
• Report Number: 1710034-2022-00795
• Device Sequence Number: 4951689
• Product Code: FOZ
• UDI-Device Identifier: 30382903835301
• UDI-Public: (01)30382903835301
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K102520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 383530
• Device Catalogue Number: 383530
• Device Lot Number: 2182100
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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