Event summary: as reported, during preparation for an unknown procedure, a micropuncture transitionless pedal access set was found to be missing from the outer package due to an incomplete or missing seal.No patient harm has been reported.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints on the product lot or on lots packaged and sealed by the same operator.There is no evidence of any additional nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which state, ¿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 available information, cook has concluded that a manufacturing deficiency contributed to this incident.There is no evidence that additional product was affected or that non-conforming product from this lot exists in house or in the field.The responsible personnel was retrained to prevent this failure from recurring.Cook will continue monitoring of similar complaints and has 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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