Investigation ¿ evaluation: reviews of the complaint history, device history record, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one unopened step suprapubic introducer was returned for investigation.The visual examination also confirmed that the sealed, unopened package contained a hair-like fiber.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ".Do not use the product if there is a doubt as to whether the product is sterile.Upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to manufacturing and quality control.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.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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