Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Jainfeng medical device co.Ltd (taiwan) informed cook on 10feb2022 of an incident involving a torcon nb advantage angiographic catheter (rpn: hnb5.0-38-40-p-ns-kmp) from lot 14401405.When the catheter was removed from the box it was discovered that there was a hair in the package.This was discovered at the distributor.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as a visual inspection of the returned device were conducted during the investigation.One torcon nb advantage angiographic catheter was received in unused condition.Visual examination revealed that there is a hair like fiber sealed inside the inner pouch.The complaint failure mode was confirmed, and the device was confirmed to be manufactured out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot revealed no relevant nonconformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_ce_angio88_rev6] ¿angiography catheters,¿ 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 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, inspection of the returned device, and the results of the investigation, cook has concluded that quality control deficiency contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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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