It was reported, while putting away stock and prior to opening the package for a filiform double pigtail ureteral stent set, a hair was discovered in the sealed perimeter of the packaging.There was no use on patients.No adverse effects have been reported due to the alleged malfunction.
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Investigation evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Visual examination of the unopened package confirmed a hair-like fiber sealed inside of the packaging.A review of the device history record found no non-conformances.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The complaint was confirmed based on customer testimony and analysis of the returned device.The complaint device was determined to be out of specification.Due to the individual nature of inspecting finished products for foreign matter one nonconformance does not indicate additional non conformances in the lot.Additionally, there have been no other complaints filed for this lot.It was concluded, the cause was traced to manufacturing and quality control deficiency.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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