Two (2) samples were received in used conditions, without their certificate of decontamination and without their original packaging inside a ziploc bag.Visual inspection was performed at 12 under normal lighting to received unit, in order to detect any damage on the cuff or airline.It was observed that the units have a blue condition on the pilot balloon, connector and tube.The complaint is confirmed.Functional test was performed where samples were filled with water to see if they turn blue.The samples did not turn blue after filling with water.They remained in the blue condition as received.By other side, after the water was removed from cuff, the water was clean.It is concluded that blue condition reported by the customer is a blue foreign substance since it is not adhered to samples material.Therefore, based on visual inspection and reviewing of manufacturing process where no sources of blue contamination were found, the most probable root cause is that damaged occurred after product left shm facilities.No corrective actions were taken.No lot number was provided; therefore, device history record (dhr) review could not be completed.Product information and pma/510(k) are unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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