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

Model Number	2790Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer.The product lot number was not provided, therefore, a review of the device history record could not be performed.A review of the complaint database revealed some potential causes from similar issues reported and evaluated.Of those returned, excessive force, misuse of the device, and small voids / holes have been found in the buckles.Being that the unit was used on a combative patient the likely cause was excessive force that caused the buckle to break.The instructions for use contraindications state; 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.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Warnings state: before each use, check cuffs 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.Additional or different body or limb restraints may be needed: 1.If the patient pulls violently against the bed straps.2.To reduce the risk of the patient getting access to the line/wound/tube site.3.To prevent the patient from flailing or bucking up and down and causing self-injury.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.(b)(4) / manufacturer reference file (b)(4).
Event or Problem Description
Reported via fda (b)(4).Complaint description: wrist restraint was borrowed from one of our other inpatient user facilities.During attempt to apply restraints to a combative patient, staff were trying to secure the restraint to the bed when the plastic snap on the wrist restraint broke and made the restraint unusable.A new restraint was applied to the patient's wrist.Per nursing leadership review, the restraints were applied correctly and additional restrain education is being provided.The triangles on the norix platform bed were not being utilized during the above event.Product is not available for return.

• Brand Name: QUICK-RELEASE TWICE-AS-TOUGH CUFFS
• 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 ; 9207514300
• MDR Report Key: 20785533
• Report Number: 2182318-2024-00159
• Device Sequence Number: 12025141
• Product Code: FMQ
• UDI-Device Identifier: 10190676003379
• UDI-Public: 10190676003379
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/28/2024

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: 2790Q
• Device Catalogue Number: 2790Q
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American