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

Model Number 2700QL

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Customer is going to return product # 2700ql due to complaint.Customer stated patient broke out of tat restraints due to broken buckle.No explanation on how the buckle broke.Product # 2700ql with lot# 1288t070.

Manufacturer Narrative

Product is scheduled to be returned but has not been received in by manufacturing site at the time of this report.Therefore, this report is based solely on the information provided by the customer.Customer confirmed the patient was combative and fighting against the restraints.The buckle of the wrist restraint broke and patient was trying to undo velcro with force.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.Clinicians may need to use additional interventions in conjunction with restraints.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.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: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15932428
• MDR Text Key: 307726077
• Report Number: 2182318-2022-00137
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002808
• UDI-Public: 10190676002808
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2022

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: 2700QL
• Device Catalogue Number: 2700QL
• Device Lot Number: 1228T070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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