A device history record (dhr) review could not be reviewed because the lot number was reported as unknown, however all dhr¿s are reviewed for accuracy prior to product release.A video was provided by the customer and upon reviewing the video, it was noticed that the customer was removing the lid from the container and the lid cracked.It was determined that the customer/user violated numerous instructions in the instruction for use (ifu) including: instruction: place container in wall enclosure or bracket and lock with key if it is a locking unit.Precautions/warnings: never put hands into container opening.Never attempt to disassemble container.Do not strike, tap, shake, or manipulate container for any reason.Use container with appropriate covidien hardware that fits with the covidien container of choice.The root cause of the lid breaking was use error (removing the lid).The reported complaint was not related to a manufacturing issue.No adverse trending in internal non-conformances or complaints related to this issue were identified.
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