The international customer reported that the size 7 versatube¿ tapered tracheostomy tube leaked at the cuff.The cuff seal was reportedly maintained at 20 cm h2o.The device was placed on (b)(6) 2018.The patient required a bronchoscope, as well as the insertion of a new versatube.When the intensive care equipment nurse filled the leaking cuff with water in an attempt to identify the location of the leak, water streamed out from two small holes in the cuff.The customer confirmed that the device was not kept, and is therefore unavailable for return and evaluation.
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F10-no consequences or impact to patient (2199).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed.However, a document-based investigation was performed.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 was unable to be performed as the lot number for the device was not available.A complaint history search was also unable to be performed due to the lack of a lot number.The device was not returned however photographs of the reported issue were provided.Visual examination of the returned photographs confirmed the complaint.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.With the information available the cause of this issue cannot be determined.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.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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