A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.On september 22, 2014, ten (10) new (non-activated) customer returned samples were evaluated.The actual reported complaint sample was not returned.Eight (8) of the ten samples were activated per the approved process by applying pressure and squeezing from the bottom of the pouch as identified on the product labeling.All eight returned samples activated as intended with no leaking or bursting during activation.The remaining two (2) returned samples were activated per the incorrect process by applying pressure and squeezing from the top of the pouch.Both samples burst through the bottom seal as expected, as this is not the proper method to activate the infant heel warmer.Due to our investigation, specifically to this complaint, we can understand how the infant heel warmer ruptured due to an improper method used to activate the heel warmer.It is important to review the safety and how to activate instructions printed on the pouch while using this product.This complaint will be shared with the charts/sensors/hydra focus factory to promote awareness.This complaint will also be used for trending and tracking purposes.
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