Initial report: as reported, during inspection within a distribution facility, an unknown particle was observed inside the primary package of a torcon nb advantage angiographic catheter.The device did not make contact with any patient.Investigation ¿ evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; however, photos were provided of the device.From the photos, a foreign particle can be confirmed within the sealed packaging.A document-based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.An ifu is provided with this device which states ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and no product returned, cook has concluded that a quality control deficiency likely led to the reported event.Though the device was not returned, the packaging appears to be sealed with a small unknown fiber.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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