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

Model Number	2790
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
Customer reporting a complaint on product 2790/2791.Customer states that they witnessed a patient incident where a patient that was restrained with 2790/2791 was able to rip free of the restraint.Customer states that the restraint was properly applied.No patient incident or injury was reported.
Additional Manufacturer Narrative
H3 the tm noted a conversation with ed manager.After interviewing the ed managers, it was confirmed that part 2790 was not salvaged.However, they also confirmed the limb holder did not fail.The anchor strap had slipped from the patient¿s constant thrashing.No overhand knot was used to secure anchor points.The ifu and online ifu video have been sent to the customer as reference for proper application.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The application instructions state: thread the end of the strap over the top, around the frame, at least once, and through the two d-rings.Bring the strap back over the first ring and through the second d-ring, or attach with a quick-release tie.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the d-ring.Ifu warnings state: some patients may require additional interventions in conjunction with a restraint in order to prevent injury to self or others.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.Manufacturer reference file (b)(4).

• Brand Name: NON-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: 20753022
• Report Number: 2182318-2024-00157
• Device Sequence Number: 9328971
• Product Code: FMQ
• UDI-Device Identifier: 10190676002518
• UDI-Public: 10190676002518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/25/2024

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: 2790
• Device Catalogue Number: 2790
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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