As reported, per anvisa notification (b)(4), the presence of a foreign body was observed inside the packaging of a 5f 100 cm tempo vertebral (vert) catheter.There was no reported patient injury.Customer identification was not provided in the anvisa website, and the submitter did not have more information about this case.Additional information was requested; however, could not be obtained.The device will not be returned for evaluation.
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As reported, per anvisa notification (b)(4), the presence of a foreign body was observed inside the packaging of a 5f 100 cm tempo vertebral (vert) catheter.There was no reported patient injury.Customer identification was not provided in the anvisa website, and the submitter did not have more information about this case.Without the return of the device or images for analysis, the reported customer event ¿packaging/pouch/box-foreign material in sterile packaging¿ could not be confirmed.It is possible that shipping/handling factors may have compromised the integrity of the sterile packaging.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
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