It was reported to covidien on (b)(6) 2016 that a customer had an issue with a syringe.The customer states that when the doctor aspirated fluid from a patient's knee, the doctor noticed a "long, dark, string like substance" inside the barrel.After further inspection of the material, the doctor reports that the substance is a piece of rubber that had broken off from inside the syringe and was now free-floating inside the barrel.No patient harm was reported.
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A device history record (dhr) review could not be performed since no lot number was provided.One sample was returned but confirmed it's not manufactured by the manufacturing site and no additional information was provided to determine the manufacturer of the item, so the investigation could not be performed either.Based on investigation, the reported issue and the root cause could not be determined, so no corrective and preventive actions will be taken at this time.This complaint will be closed as unconfirmed at this time.If additional information is obtained, this file may be re-opened for further investigation.
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