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

Model Number	2700Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.A review of the device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The unit passed all verification testing and met manufacturing specifications prior to being released for distribution.Based on the reported issue of the patient slamming the buckle portion of the restraint against the bed, confirms patient was in combative / agitated state.The instructions for use warns: additional or different body or limb restrains may be needed for some patients that may require additional interventions in conjunction with a restraint in order to prevent injury to self or others.Example, if the patient pulls violently against the bed straps.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.Application instructions step 3 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).H3 other text : product was discard.
Event or Problem Description
Customer reported issue with part 2700q, on (b)(6) 2024 at 10:38pm a patient was slamming and pressing the gray portion of the buckle against the bed and it cracked the buckle.No injury or incident.Item is not available for inspection as item was discarded, lot number reported was next on customers shelf lot number 4022t003.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF
• 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: 20054012
• Report Number: 2182318-2024-00108
• Device Sequence Number: 7971688
• Product Code: FMQ
• UDI-Device Identifier: 10190676002792
• UDI-Public: 10190676002792
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/25/2024

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: 2700Q
• Device Catalogue Number: 2700Q
• Device Lot Number: 4022T003
• 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: 07/25/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2024
• 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