Medical Device Failure

Dr. Duane Priddy, Plastic Failure Labs

The failure of a medical device can result if the loss of life. When a medical device fails, the device manufacturer must rapidly determine the root cause of failure and quickly develop a corrective action plan. In this case study the client manufactured a device for delivering IV fluids. The part shown below was glued into a bifurcate allowing injection of medicines into an IV line. The luer part was breaking in the bifurcate where the part was glued/mounted. Our experts utilized state of the art forensic science to determine that there was material contamination/molding issues. Once the root cause of failure was determined, our experts worked with the part manufacturer to develop a remediation plan to eliminate future failures.