MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT WITH MAXZERO, 20G X 1.0"; INTRAVASCULAR ADMINISTRATION SET

Model Number 383556

Device Problem Packaging Problem (3007)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received three photographs which displayed the product labeling with reference number: (b)(4) and lot number: 2109562.Three photographs were provided for investigation, which showed a 20g nexiva device with the needle cover, needle, and catheter that may have been caught in the seal during the packaging process.The needle cover, needle, and catheter appeared to be severed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error during the packaging process.There is a 100% in line vision inspection system that checks for the presence of components and verifies that they are in the correct location.Given the orientation that the unit would have to be in for this defect to occur, it is likely that the vision system detected this defect; however, when this type of defect is identified by the vision system an operator is alerted to realign the unit.If the operator fails to correct the misaligned unit, this type of defect may occur.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using bd nexiva single port with maxzero, 20g x 1.0" the sterility was breached.There was no report of patient impact.The following information was provided by the initial reporter: the cannula cover appeared to be broken and misshaped or flattened.

• Brand Name: BD NEXIVA SINGLE PORT WITH MAXZERO, 20G X 1.0"
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: 16151241
• MDR Text Key: 308767599
• Report Number: 1710034-2022-00916
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903835561
• UDI-Public: (01)30382903835561
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170336
• 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: 12/29/2022

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 Model Number: 383556
• Device Catalogue Number: 383556
• Device Lot Number: 2109562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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