Investigation evaluation: investigation methods used include a review of complaint history, the device history record, quality control data, and a visual inspection of the returned device.One unopened package labeled rpn (b)(4) and label lot number 8650421 was received.Visual examination of the sealed package confirmed a long dark hair like fiber trapped beneath the lid packaging tray.Based on the evidence presented by the sample, this event has been attributed to a packaging event.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history revealed no other complaints associated with the complaint device lot.Based on the information provided and results of the investigation, the cause of this issue is manufacturing related.Measures have been initiated to address this failure.Cook medical has notified the appropriate personnel and 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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