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

Model Number 2750

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: only a single tat cuff restraint for stretcher was received in for evaluation.Evaluation of the returned product found that the outer blue hook fastening tape for stretcher connecting strap has torn off.Evaluation of the failure area appears to have originated at the stitching that secures the webbing to the blue and black hook fastening tapes.The stitching is intact, but the blue hook fastening tape sewn as a secondary fastening tape of the connecting strap has torn off due to excessive force applied.During the sewing process, the stitch needle perforates the blue hook fastening tape when stitching with the webbing and the black hook fastening tape, thus weakening the blue hook fastening tape and a starting point for a tear or rip when excessive force is applied.Customer reported applying wrist cuff restraint on a combative psychiatric patient.Ifu contraindications states that 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.A device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The unit passed all verification testing and met manufacturing specifications prior to being released for distribution.A review of the complaint database did not reveal any similar events against this device in the past 5 years.Therefore, it appears this complaint was an isolated event.The possible root causes for this deficiency: caregiver not following instructions - the inner black hook and loop fastening tapes were not adhere together but instead the outer blue hook fastening tape was adhere directly to the black hook fastening tape causing to come apart when pulled.Patient is combative or very aggressive.The instruction for use was reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.The historical complaint database revealed that this was an isolated issue.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.Manufacturer reference file (b)(4).

Event Description

Customer reported via email that they had a patient who was being transported via ambulance.He was being combative psychiatric patient during transport.The posey restraints were applied to the patient's wrist and ankles to physically restrain the patient.The patient was able to start pulling the velcro off one of their restraints.He was able to get out of restraint, pulled off the spit hood, and spat at employee.

• Brand Name: TWICE-AS-TOUGH CUFFS FOR STRETCHER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise dr.; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15562238
• MDR Text Key: 306688110
• Report Number: 2182318-2022-00116
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676002815
• UDI-Public: 10190676002815
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2022

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: 2750
• Device Catalogue Number: 2750
• Device Lot Number: 1257T336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1