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

Model Number 2700Q

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

(b)(6) reported they have 3 restraints from the same lot number that have broken while being used on combative patients.Item # 2700q lot # 3135t004 limited information provided.Requesting products be sent in for qa evaluation.

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.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.Additionally, the ifu warns do not use this device on a patient who is or becomes: suicidal, highly aggressive or combative, self-destructive, or deemed to be an immediate risk to others, unless the patient is under constant supervision.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: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF
• Type of Device: 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: 17644431
• MDR Text Key: 322206593
• Report Number: 2182318-2023-00079
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002792
• UDI-Public: 10190676002792
• 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: 08/01/2023

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?: No
• Device Model Number: 2700Q
• Device Catalogue Number: 2700Q
• Device Lot Number: 3135T004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2023
• 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