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

Model Number 383531

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received 57 sealed 24g x 0.75in.Nexiva units from lot number 1155068.Additionally, 18 photos were received for investigation.Gross visual and microscopic inspection found foreign matter (fm) inside all 57 units.Additionally, one of the units (unit 5) had damage present on the y-site adapter.The defect of damaged adapter was confirmed.Microscopic inspection of the adapter found that the surface of the adapter adjacent to the raised surface appeared as though it had been scraped.When looking at the adapter from a side view the rounded surface flattened out near the defect.This indicated that the damage had likely been caused during manufacturing.During manufacturing, this may occur due to improper setup or misalignment of parts/tooling.Visual inspections are performed per the quality plan to mitigate the occurrence of this defect.A device history record review showed no non-conformance's associated with this issue during the production of this batch.The appropriate personnel have been notified.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 Description

It was reported that the y-site adapter of the bd nexiva¿ closed iv catheter system was found damaged.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided via the bdj investigation team: "one of the units (unit 5) had damage present on the y-site adapter".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: 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: 14120782
• MDR Text Key: 289524438
• Report Number: 1710034-2022-00187
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835318
• UDI-Public: 30382903835318
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2022

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
• Device Operator: Other
• Device Expiration Date: 05/31/2024
• Device Model Number: 383531
• Device Catalogue Number: 383531
• Device Lot Number: 1155068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1