Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.A review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The used complaint device was returned with biomatter on all lumens for evaluation.A wire guide was passed through the lumen that connects to the blue extension tube and a 1cm rupture was confirmed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Possible causes for the failure include use of excessive force, exceeding the pressure limit during administration, manufacturing errors, securement of device to the patient or occlusion of catheter during use.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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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