H6: method code: communication/interviews (4111).Event summary: it is reported a distributor received a roadrunner the firm hydrophilic wire guide with hair sealed in the package.This device was never sent to a user facility and did not make patient contact.Investigation - evaluation.Reviews of the complaint history, device history record, and quality control procedures and a visual inspection of the device were conducted during the investigation.One device was returned within the sealed packaging for investigation.Upon visual inspection, a piece of dark hair was found within the sealed pouch.The hair was free-floating within the pouch.A document-based investigation evaluation was performed.No related non-conformances were found, and no other lot-related complaints have been received.There is no evidence of further nonconforming devices from the complaint lot in house or in the field.Based on the information available, cook has concluded that a manufacturing and quality control deficiency contributed to this event.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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