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

Model Number 2799

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

H3: visual finding only a single restraint was received, usually sold in pair.The product is received in two pieces.The box stitch for the bed connecting strap is broken causing the product to come apart.No other abnormalities have been observed.Evaluation found the product has broken box stitches for the bed connecting strap causing the product to come apart.The broken stitches are located in-between the webbing of the wrist strap and the overlapped bed-connecting strap.The ends of the exposed threads have some unraveling with elongated thread fibers.Seam separation on the box stitch is a known issue and has been addressed via dco-3853.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Per the ifu: 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 the device is damaged or if unable to lock.Additionally, the ifu warns: 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.Additional or different body or limb restraints may be needed if the patient pulls violently against the bed straps.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).

Event Description

Customer reporting complaint on product # 2799.Customer states that the restraint was in use for 2 hours and the box seams ripped off the strap.No injuries/death as result of patient incident.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• 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: 18547815
• MDR Text Key: 333499334
• Report Number: 2182318-2023-00131
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002693
• UDI-Public: 10190676002693
• 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: 12/29/2023

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: 2799
• Device Catalogue Number: 2799
• Device Lot Number: 2283T151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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