Blank fields on this form indicate the information is unchanged, unknown, or unavailable.D10 ¿ product received on: 25sep2020.Investigation ¿ evaluation.Bemel logistics / advanced informed cook of an event that occurred in colombia where the distributor received an ultrathane mac-loc locking loop multipurpose drainage set in march that had perforated packaging.No patient care was impacted.A review of the complaint history, device history record, drawing, instructions for use (ifu), and quality control of the device, as well as a visual inspection, were conducted during the investigation.Cook received one sealed device set.A small perforation was observed in the blue plastic tray.Additionally, a document based investigation evaluation was performed.The device packaging is 100% inspected for defects.The design history file contains controls related to the failure.The device is shipped with instruction for use (ifu) which 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.¿ a review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot records no nonconformances.A complaint history search was conducted and no additional complaints from the lot were found.Therefore, there is no evidence of nonconformance material in house or in the field.Based on the device failure analysis, device history record, and device master record, there is no indication the device was manufactured out of specification.Cook confirmed that the blue plastic tray was perforated.Based on the information provided, examination of the returned product, and the results of the investigation, the most likely cause of this event is shipping damage.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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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