Event summary: as reported, the packaging of a balloon uterine stent was found damaged before the device could be used.A photo provided by the user shows a pinhole in the device packaging.The procedure was completed using a new device.No adverse effect to the patient has been reported as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Photos provided by the user appear to show a pinhole in the device packaging.A document-based investigation evaluation was performed.One relevant nonconformance was recorded; all affected product was scrapped.There have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No 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.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, "sterile if the package is unopened or damaged.Do not use if package is broken." based on the available information, cook has concluded that transport and/or storage of the complaint device contributed to the incident.Cook will continue monitoring of similar complaints and has 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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