MAUDE Adverse Event Report: TIDI PRODUCTS UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE; RESTRAINT, PROTECTIVE

Model Number 2700QL

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

Tm reporting incident of restraint ripping while in use.Patient was able to get out of restraint.The date the issue was discovered is unknown and no patient incident or injury was reported.

Manufacturer Narrative

Evaluation summary: visual findings observed 1 single wrist restraint was returned, sold in pairs.The red hook fastener is torn.No issues found with the two quick-release buckles.No issues found to the webbing for the wrist cuff and bed-connecting strap.All labels are present and legible.Evaluation found the torn red hook fastener (fastening tape) cuff appears to have originated at the box stitch that secures the webbing to the hook fastener.The box stitch is intact and the red hook fastener sewn with the box stitch has torn suggesting excessive force was applied resulting in the failure.The root cause could not be determined only suggested possible causes such as product applied to a combative patient who exerted enough force beyond the threshold to cause the failure, or an application issue.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.Discard if device is damaged.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 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: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE
• 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: 14112287
• MDR Text Key: 298804109
• Report Number: 2182318-2022-00027
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2700QL
• Device Catalogue Number: 2700QL
• Device Lot Number: 1306T041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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