H3 evaluation of the returned product found the blue hook fastener on one of the single restraints is torn apart.Bite marks with tensile strength failure observed on one side of the torn area indicating the origin of the failure.The other single restraint was undamaged.All quick release buckles and straps appear normal.The possible root cause for this deficiency is that the bed connecting straps of the restraints were not applied properly when attaching to the bed mechanism making the cuffs to be close enough to the patient¿s mouth when pulled excessively causing the blue hook fastener to be torn apart.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, cracked or broken buckles or locks, and/or that hook-and-loop adheres securely, as these may allow patient to remove cuff.Additionally, the ifu warns 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.Application instructions step 2 state once the buckle is in place and the strap is secured to the frame, pull on the excess strap end to adjust to the desired length between the cuff and the attachment point.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.Secure the remaining strap end(s) out of the reach of the patient.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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).
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