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

Model Number	2799
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: visual findings observed only a single restraint was received, normally they are sold in pairs.The product was received in two pieces.The neoprene fabric (foam pad material) has been torn off, and the origin of the failure is on the stitching where neoprene fabric and webbing are sewn together.A sample product from inventory with a lot number 3199t168 was pulled to replicate the torn neoprene fabric failure.The sample product was applied on the ankle and wrist as prescribed in the ifu, but the failure could not be replicated.However, when the hook and look fasteners were just aligned and ignoring the ifu step 2 on applying the cuff to slide one finger between the cuff and the wrist, the failure was replicated.Possible root cause for this deficiency is that the product was applied on a patient with a small wrist/ankle, the ifu step 2 on applying the cuffs was not followed creating too much slack between the cuff and the patient's wrist/ankle, and in the process of getting out of the cuff the patient was grabbing the neoprene fabric leading the cuff 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.Per the ifu: 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.Additionally, the ifu warns: 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.And additional or different body or limb restraints may be needed: if the patient pulls violently against the bed straps.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.Manufacture reference file: (b)(4).
Event or Problem Description
Customer is reporting a complaint on product # 2799 witha lot# 3034t048 product.The foam ripped away from the locked restraint strap.This allowed the patient to get out of the restraints, no injuries to patient or staff.

• Brand Name: LOCKING 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: 17840098
• Report Number: 2182318-2023-00089
• Device Sequence Number: 12686586
• Product Code: FMQ
• UDI-Device Identifier: 10190676002693
• UDI-Public: 10190676002693
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/01/2023

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: 2799
• Device Catalogue Number: 2799
• Device Lot Number: 3034T048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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