Medical device component failure investigation by X-ray Microtomography

A client’s investigation into cannula leakage through the injection port in a production batch was supported by RSSL in order to determine the cause, as well as potentially preventing a recurrence of this issue.

cannula

Background

A client’s investigation into cannula leakage through the injection port in a production batch was supported by RSSL in order to determine the cause, as well as potentially preventing a recurrence of this issue.


Approach

Light microscopy of the injection port and the Luer lock port did not reveal any indication of what was causing the leakage. It was determined that a destructive method to extract the inner cannula component, for further examination, could cause unintentional damage and potentially mislead the investigation.

X-ray microtomography (XRT) was used to non-destructively image and digitally isolate the internal component of the cannula. Image analysis and measurements were carried out, which revealed a structural inconsistency of the component that caused a fitting problem of an internal component. This ultimately caused the medical drip solution to escape via the syringe connector port.


Results

The ability to examine internal components of medical devices in situ and non-destructively was key to identifying the fault, which would have been difficult or impossible if the device had to be dismantled to investigate the individual components.






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