The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be " inadequate component selection component failures, damage, or deterioration ".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: " always unplug purewick¿ urine collection system before cleaning or when not in use.Do not immerse the purewick¿ urine collection system in water.As with most electrical devices, electrical parts in this system are electrically live even when the power is off.To reduce the risk of electric shock, if the purewick¿ urine collection system falls into water, unplug immediately.Do not reach into the water to retrieve it." " warning: this device should not be used in oxygen rich environments or in conjunction with flammable anesthetics." " when the purewick¿ urine collection system has been stored in a very cold environment (down to -13°f or -25°c), please allow the device to sit for approximately 90 minutes at room temperature (approximately 68°f or 20°c) before use." " when the purewick¿ urine collection system has been stored in a very warm environment (up to 158°f or 70°c), please allow the device to sit for approximately 90 minutes at room temperature (approximately 68°f or 20°c) before use.¿ h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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