Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer.Customer confirmed product was used on a large patient 6'5 who became aggressive and paranoid.Historical complaint data review found similar complaints received for patients being able to self-release from this device or similar device.Of those complaint devices that were returned and evaluated, they were found to meet specification, or found that the 3-point buckle middle tab appeared not to be completely engaged or secured, causing the buckle to become a 2-point buckle.The purpose of the middle tab is to add a degree of difficulty for the patient who is attempting to escape the restraint.The ifu describes closing the buckle by sliding the male and female components together.The only distinct way to ensure the buckle is completely engaged, is the sound made when the male and female components are engaged.The ifu states do not use this device on a patient who is or becomes: suicidal, highly aggressive or combative, self-destructive, or deemed to be an immediate risk to others, unless the patient is under constant supervision.At this time, there is no evidence that a manufacturing nonconformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).Product not returned.
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