MAUDE Adverse Event Report: TIDI PRODUCTS LOCKING TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number 2799

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer reported via email the restraint broke at the strap to cuff area where the stitching is.Patient was average size and not on drugs but was psychotic.The date the issue was discovered is unknown and no patient incident or injury was reported.

Manufacturer Narrative

Evaluation summary visual findings observed one single 2799 restraint returned (sold in pairs).No keys were returned.Restraint was received in 2 pieces - detached at the box stitch which secures the bed connecting strap.Lint found in the red and black hooks.Scratches and indentations found on both key-lock buckles.Fuzzy/frayed edges observed the black webbing.Labeling is present and legible.Evaluation found that the square box stitch which secures the bed-connecting to the cuff are coming apart.The broken stitches are located in-between the webbing of the wrist strap and the overlapped bed-connecting strap.Close inspection of the box x stitch shows the top and bottom of the stitch remains complete/intact, and the broken or loose threads are contained within the plies of the webbing.Observing the ends of the threads through magnified glasses, there is a combination of threads that appear to have been pulled and threads that may have been cut.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, but the root cause cannot be determined because there was not enough information provided by the customer.Per the ifu states do 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.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.Discard if device is damaged.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 warrant.Manufacturer reference file (b)(4).

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 14162513
• MDR Text Key: 290556889
• Report Number: 2182318-2022-00031
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2799
• Device Catalogue Number: 2799
• Device Lot Number: 1287T044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1