Investigation/evaluation: a review of the complaint history, device history record, quality control, visual and functional inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed a crack extending from the hex nut towards the center female connection.Functional testing confirmed the device leaked from the area of the crack.As no instructions for use are provided with this device, no review of instructions, indications, warnings, or precautions could be completed.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the examination of the returned product, investigation has concluded a cause for this event cannot be established.Appropriate measures have been initiated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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