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

Catalog Number 383557

Device Problem Packaging Problem (3007)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Address information was not able to be obtained, therefore, nj was used as a place holder.H.6 investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed an opened 20g x 1.25in.Nexiva unit.A gross visual inspection of the unit found that the extension tubing, needle, needle cover, and catheter tubing had been cut.Additionally, voids in the packaging seal were present and parts of the extension tubing where flattened.Based on these observations, it is likely that the unit was caught in the seal of the packaging.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error.This type of defect may occur during manufacturing due to misalignment when the pick and place robot is placing the unit in the package.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.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.H3 other text : see h.10.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector sterility of the product was compromised it was sliced into 3 pieces and the needle was flat.The following information was provided by the initial reporter: it was sliced into 3 pieces, the needle was flat.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH BD MAXZERO¿ NEEDLE-FREE CONNECTOR
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17557354
• MDR Text Key: 321258082
• Report Number: 1710034-2023-00921
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903835577
• UDI-Public: 00382903835577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383557
• Device Lot Number: 3059752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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