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

Model Number	383538
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received several representative samples submitted for evaluation.The reported issue was confirmed since two of the samples failed our penetration testing.The failed samples were then inspected with a microscope and needle damage was found at the tip.Bd determined that the root cause of the failure can be associated to the manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for 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 collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd nexiva¿ dual port closed iv catheter system needle tip was damaged.The following information was provided by the initial reporter: "dull needle on specific lot." via bd investigation: "the failed samples were then inspected with a microscope and needle damage was found at the tip.".

• Brand Name: BD NEXIVA DUAL PORT 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
• MDR Report Key: 12208040
• Report Number: 1710034-2021-00599
• Device Sequence Number: 14555917
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: 02/28/2023
• Device Model Number: 383538
• Device Catalogue Number: 383538
• Device Lot Number: 0064637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1