Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation bemel logistics / advanced (colombia) informed cook on (b)(6) 2021 that the packaging on a clm-10.2-rh-npas-nt (ultrathane mac-loc locking loop multipurpose drainage set) from lot 13296885 was perforated at the distributor.There was no patient impact.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One device in its original packaging was returned to cook for evaluation.Upon visual inspection, a small tear in the clear film over the plastic tray was noted.Cook has concluded that the device was manufactured to 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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (13296885) did not reveal any recorded non-conformances related to the reported failure mode.A database search did not identify any other events associated with the reported device lot.Given 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 ifu supplied with the device, ifu t_multi_rev5, states the following in relation 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 information provided, inspection of the returned devices, and the results of the investigation, a definitive root cause for this event has been trace to transport/storage.As the film around the blue plastic tray was perforated, shipping damage likely occurred.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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