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

Model Number 2794

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H3 the product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.The instructions for use ifu were reviewed and determined to provide adequate instructions and warning for the 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, 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.Application instructions states pass the end of the limb strap over the top of the cuff and through the two d-rings on the cuff.Bring the strap back over the first ring and through the two d-rings on the cuff.Slide one finger flat between the cuff and limb strap.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 2023-00296.

Event Description

Customer reports a complaint on product # 2792, 2793, 2794, & 2795.Customer states that patients are able to get out of the restraint cuffs.Staff was able to demostrate that the d-ring was able to fit inside itself and release.Staff reported that this can happen when they tighten the restraint and the patient can also release the restraint with their teeth.Lot# 2792 - 1251t055, 2794 - 2228t047, & 2793 - 2083t023 & 2220t109.

• Brand Name: CONNECTED TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16773621
• MDR Text Key: 313756730
• Report Number: 2182318-2023-00025
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002730
• UDI-Public: 10190676002730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2023

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: 2794
• Device Catalogue Number: 2794
• Device Lot Number: 2228T047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1