Medical Device Removed from Market Due to Life Threatening Manufacturing Error

This May Ventlab LLC. in Grand Rapids, Michigan, initiated a voluntary recall of resuscitator bags after discovering that the duckbill valve was sticking thereby preventing air to pass through the patient valve. The bags affected could be life threatening if used, as the lack of airflow could result in patient hypoxia and hypoventilation.

The product defect is thought to be due to incomplete curing during the manufacturing process. This error only effects certain lots and the full list of suspected failed lots can be found at:

 http://www.fda.gov/Safety/Recalls/ucm397682.htm

Manufacturing errors such as incomplete curing are not an unusual failure, however they have dire consequences. There have been 31 reports of delayed medical care due to professionals having to use two or three of the resuscitation devices to assist a patient. There has also be one reported injury due to the defective bags.

Especially when it comes to medical devices, product defects and failures are of the utmost concern. Companies must take immediate action to not only remove the defective product from the market, but also to solve the production error by finding the source of the product defect. When this occurs the manufacturer is often unable to identify the cause of the failure and must consult expert help to pin point the defect source.

Avomeen Analytical Services provides exceptional product failure analysis. Utilizing state-of-the-art instrumentation and methodology our scientists examine products at the elemental level to isolate contaminants, compare good vs. batches of product, and determine the source of a manufacturing failure. These services help companies such as Ventlab identify and address their problem, allowing them to quickly resume production and sale of their medical devices.

More information regarding Avomeen’s Product Defect/Failure Analysis can be found on our website at:

http://www.avomeen.com/services/failure-analysis-testing-laboratory

For immediate assistance with product analysis call us at 800-930-5450 or email Scientist@avomeen.com

We look forward to working with you to solve your complex production problems!