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

Model Number	2700QL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Additional product returned.The customer is stating that patients are ripping through the thin part of the material.The staff did not witness how it happened and it was discovered during 15 min safety check.
Additional Manufacturer Narrative
H3: visual findings observed only a single restraint was received in for evaluation.Additionally, there is a loose red hook fastener that came with the restraint, and it belongs to other restraints not being returned.Evaluation of the returned product found the red hook fastener on the single restraint is torn apart.Bite marks with tensile strength failure observed on one side of the torn area indicating the origin of the failure.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 closed enough to the patient's mouth when pulled excessively causing the red 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).

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956
• MDR Report Key: 18297439
• Report Number: 2182318-2023-00119
• Device Sequence Number: 17954627
• Product Code: FMQ
• UDI-Device Identifier: 10190676002808
• UDI-Public: 10190676002808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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: 3054T006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown