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Model Number 2798 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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Tm reported complaint via email.Two restraint skus 2798 and 2799 had tearing from the strap, in the sewen area.An incident occurred on (b)(6) 2023, staff memeber was injured.No lot number was located on either product, customer states they've been using these products for at least two years.Request to have product returned for qa evaluation.
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Manufacturer Narrative
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Product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.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 to before each use, check cuff s and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.The ifu also provided extra warning to not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.At this time there is no evidence that a manufacturing non-conformity 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).
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Manufacturer Narrative
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H3: evaluation of the device found tearing on the square box stitches which secure the bed-connecting strap to the cuff.The broken stitches are located in-between the webbing of the wrist strap and the overlapped bed-connecting strap.The ends of the exposed threads have some unraveling with elongated thread fibers.The broken threads at the box stitch have been identified as the failure and was the result of tensile forces applied beyond the threshold of the box stitch strength.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 to before each use, check cuff s and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.The ifu also provided extra warning to not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning 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).
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Event Description
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Supplemental medwatch being sent for additional information.
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Search Alerts/Recalls
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