Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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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Summary of event: as reported, a cook bakri postpartum balloon with rapid instillation components was difficult to inflate.Investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook could not complete a review of the device history record or complaint history due to a lack of lot information from the user facility.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based upon the available information and results of the investigation, cook has concluded that a definitive cause of the reported event could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.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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