0
Research Papers

Performance Testing of Huber Needles for Coring of Port Septa

[+] Author and Article Information
Oleg Vesnovsky

Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD 20993oleg.vesnovsky@fda.hhs.gov

Jon P. Casamento, Matthew R. Schwerin, William A. Herman, Steven K. Pollack, Laurence W. Grossman

Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD 20993

Mary E. Brooks, Marilyn N. Flack

Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD 20993

Betty W. Collins

Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD 20993

J. Med. Devices 4(3), 031008 (Sep 08, 2010) (7 pages) doi:10.1115/1.4001866 History: Received April 13, 2010; Revised May 11, 2010; Published September 08, 2010; Online September 08, 2010

The Food and Drug Administration received complaints of Huber needles creating cores in the septa of ports of gastric banding devices. One of these complaints represented a cluster of similar events, even though no deviations from design specifications or recommended practices were subsequently identified by the manufacturer. The authors conducted this comparative investigation of off-the-shelf Huber needles and ports from several manufacturers to determine if engineering parameters could be identified that could account for the coring complaints. Huber needles from ten manufacturers were evaluated for coring using intravascular access ports from five manufacturers. A detailed optical analysis was also performed to identify needle features that would possibly account for coring. The majority of the tested needles performed as they should, i.e., they perforated the port septa without creating cores. However, needles that did produce cores were found to have sharp edges at the heel edge of the needle lumen, the edge of the ground bevel opposite from the needle tip that opens to the inner surface of the cannula tube. Manufacturing processes, which dulled or rounded the sharp heel of the bevel after bevel grinding, prevented coring. As a result of this investigation one manufacturer voluntarily recalled their product and another manufacturer implemented coring testing as part of their quality control. To prevent coring needles from entering the market as a result of manufacturing flaws, optical inspection of the heel edge and coring testing should be performed as part of routine quality control.

FIGURES IN THIS ARTICLE
<>
Copyright © 2010 by American Society of Mechanical Engineers2010 by American Society of Mechanical EngineersThe United States Government retains, and by accepting the article for publication, the publisher acknowledges that the United States Government retains, a non-exclusive, paid-up, irrevocable, worldwide license to publish or reproduce the published form of this work, or allow others to do so, for United States Government purposes.
Topics: needles , Testing
Your Session has timed out. Please sign back in to continue.

References

Figures

Grahic Jump Location
Figure 1

Images of the needle bevel and lumen face of the tested Huber needles. The numeric code designates the manufacturer.

Grahic Jump Location
Figure 2

Port pressurization apparatus for the gastric banding port. This image was made immediately following a needle test found to produce a core. Note the fluid buildup in image (a) and the core protruding from the septum in image (b).

Grahic Jump Location
Figure 3

Images of a needle bevel and the septal core it produced. Figure (b) shows the resultant core against a millimeter scale.

Grahic Jump Location
Figure 4

Optical microscopy images of the heels of test needles. Original magnification is 252×.

Grahic Jump Location
Figure 5

Optical images of the heel of the needles from manufacturer 1 shown in Table 1. Note the sharp heel edges of all except needle 1-B. All of these needles except needle 1-B produced cores.

Grahic Jump Location
Figure 6

Optical images of the heels of 24 needles from manufacturer 1. Those in (a) were from the first box tested. Those from (b) were from a second lot. Note that only the first three images in (a) have rounded heels while all the heels in (b) are rounded.

Grahic Jump Location
Figure 7

Optical images of the bevel heels from the first tested lot of manufacturer 3. All the heels show sharp edges. These sharp edges were evident on all the needles examined from this manufacturer. Original magnification 63×.

Grahic Jump Location
Figure 8

Optical images of the needles prior to being subjected to cross-sectional analysis. Image (a) is the needle from manufacturer 3. Image (b) is one of the two identical needles from manufacturer 1.

Grahic Jump Location
Figure 9

Optical cross-sectional images of a needle from manufacturer 3. This needle has a sharp heel and produced a core during testing.

Grahic Jump Location
Figure 10

Optical cross-sectional image of a needle from manufacturer 1. This needle has a sharp heel and also produced a core during testing.

Grahic Jump Location
Figure 11

Optical cross-sectional image of a needle from manufacturer 1 that did not produce a core during testing. Note the plastic deformation of the tip when viewed at the highest magnification.

Grahic Jump Location
Figure 12

Cross sections of needles from the eight manufacturers that did not produce any cores during the testing reported in Table 1

Grahic Jump Location
Figure 13

Oblique angle optical images of the bevels of a representative needle from each of the ten manufacturers

Grahic Jump Location
Figure 14

Offset from the needle shaft at the tip and the heel edge for manufacturer 1 with “sharp” (a) and “dull” (c) heel edge; and manufacturer 3 (b)

Tables

Errata

Discussions

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging and repositioning the boxes below.

Related Journal Articles
Related eBook Content
Topic Collections

Sorry! You do not have access to this content. For assistance or to subscribe, please contact us:

  • TELEPHONE: 1-800-843-2763 (Toll-free in the USA)
  • EMAIL: asmedigitalcollection@asme.org
Sign In