Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation ifs miami (colombia) contacted cook on (b)(6) 2023 concerning a neff percutaneous access set (rpn: npas-104-rh-nt, lot# 15037452).The distributor found foreign matter in the package on (b)(6) 2023.No patient contact was made.Reviews of the documentation, including the complaint history, device history record and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One unopened neff percutaneous access set was returned for evaluation.Upon a visual inspection of the device, a foreign particle was found near the distal tip of the dchn needle.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified to ensure this nonconformance does not leave the house.A review of the device history record (dhr) for lot 15037452 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review product labeling, as this device is not supplied with an instruction for use (ifu) pamphlet.Evidence gathered from a review of the dmr, dhr and device failure analysis suggests that the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive cause for the failure could be attributed to a quality control deficiency.The appropriate personnel have been notified.Per the risk assessment no further action is required.Cook will continue to monitor for similar complaints.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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