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Tamper Resistant Syringe Assembly Patent Application

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Summary

The USPTO has published a patent application (US20260083918A1) for a tamper-evident and tamper-resistant syringe assembly filed by Civica, Inc. The application describes devices and methods to prevent tampering with pre-filled syringes and provide evidence of attempted access.

What changed

This document is a published patent application for a tamper-resistant and tamper-evident syringe assembly, filed by Civica, Inc. The application details a small, cost-effective device designed to cover the ends of pre-filled syringes, preventing unauthorized access and indicating any tampering attempts through its wrapper. The invention also includes a method for wrapping the device and syringe, where the wrapper itself provides evidence of tampering and is designed for easy removal during intended use.

While this is a patent application and not a regulation, it signals potential future product development and intellectual property in the medical device space. Companies involved in manufacturing pre-filled syringes or related safety components should be aware of this technology. Compliance officers in the pharmaceutical and medical device sectors may wish to monitor the progress of this patent application and similar innovations to understand evolving product safety standards and potential market shifts.

Source document (simplified)

← USPTO Patent Applications

TAMPER RESISTANT AND TAMPER EVIDENT SYRINGE ASSEMBLY

Application US20260083918A1 Kind: A1 Mar 26, 2026

Assignee

CIVICA, INC.

Inventors

Brian George, Alex Crawford

Abstract

Devices and methods are disclosed herein for a tamper evident and tamper resistant device for a syringe. The small size of the device reduces costs related to production as well as preserves space in medical carts or other medical storage areas. The device includes two ends connected via a shaft. The two ends are shaped to be complementary to each end of the syringe, particularly to cover the ends of a pre-filled syringe to prevent access for potential tampering. Also disclosed is a wrapper and method of wrapping the device and the syringe where removal of the wrapping or attempted access to the syringe provides evidence of tampering. The wrapping can also be perforated to allow for ease of removal during actual intended use of the pre-filled syringe.

CPC Classifications

A61M 5/3202 A61M 5/31501

Filing Date

2024-09-25

Application No.

18895471

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Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
USPTO
Instrument
Notice
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Document ID
US20260083918A1

Who this affects

Applies to
Drug manufacturers Medical device makers
Industry sector
3254 Pharmaceutical Manufacturing 3345 Medical Device Manufacturing
Activity scope
Drug Labeling Product Safety
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Product Development
Compliance frameworks
FDA 21 CFR Part 11
Topics
Product Safety Intellectual Property

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