Manufacturer evaluation: although the complaint device was returned for examination, it was inadvertently discarded prior to being investigated.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.However, the indicators on the us906 locks are sensitive to light and storage conditions.The us906 instructions for use (ifu) on the label states to store in a cool, dry place while maintaining temperatures between 15°c/60°f and 30°c/86°f.Significant changes in storage conditions for prolonged periods can have an adverse effect on the product.Although minor variations over short periods of time will have little or no effect on product, extreme storage conditions, such as exposure to direct sunlight and/or storage on top of or near heat source should be avoided.Us906 should not be used if the indicator dot color has changed prior to being processed.Adherence to the following guidelines will act to minimize recurrence of this failure mode: · avoid prolonged exposure to direct sunlight or uv light.· avoid extreme temperature storage conditions.· avoid exposure to residual cleaning agents that may contain bleach, hydrogen peroxide, or other substances that could have an adverse impact to chemical indicators.Although the steam ster locks orange (material # us906) lot number was provided, the associated lot number for the indicator dot component was not available.Therefore, the device history records (dhr) were not able to be reviewed.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.No further investigation activities are required.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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