It was reported, the outer sheath of a triforce peripheral crossing set came out of the plastic case and punctured the peel away packaging, rendering it non-sterile.The product was part of the sales rep stock, so no patient was involved.
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Description of event: it was reported, the outer sheath of a triforce peripheral crossing set came out of the plastic case and punctured the peel away packaging, rendering it non-sterile.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, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one sealed kcxs-5.0-35-65-rb-0/dav-hc to cook for investigation.Physical examination of the returned device showed that the clear film is torn at that the bottom of pouch.It is suspected that the plastic packing tray punctured the sterile pouch clear front film.There is no evidence from device failure analysis the device was manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that 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 instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied ¿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 to whether the product is sterile.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that the transport, storage, and handling of the complaint device contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook 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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