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

Model Number	2795
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer is reporting a complaint on product # 2795, lot # 3143t059.Customer states that a patient was able to remove herself from her restraint because the velcro ripped off the cuff.Product has only been washed twice.Pictures have been sent to quality.A rn was assaulted but not injured as a result.Advise tech serv once the inspection has been completed.
Additional 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: (b)(4).H3 other text : product not returned yet.
Additional Manufacturer Narrative
H3 evaluation of the returned product found the red hook fastener on one of the cuffs is torn and has separated from the product.The tear originates where the cuff and hook fasteners are sewn together.Tensile strength failure found at the edges of the broken strap suggesting tension was applied.Possible root causes, tension applied by the patient -combative /agitated, incorrect sewing machine settings causing stitching to become too tight, or the patient did not have their hands in place then causing the velcro to rip.A review of the complaint database did not reveal any similar events against this issue in the past two years.Therefore, it appears this complaint was an isolated event.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 (b)(4).
Event or Problem Description
Supplemental medwatch being sent for additional information.

• Brand Name: CONNECTED TWICE-AS-TOUGH CUFFS
• Common Device Name: 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: 18132090
• Report Number: 2182318-2023-00108
• Device Sequence Number: 7753252
• Product Code: FMQ
• UDI-Device Identifier: 10190676002747
• UDI-Public: 10190676002747
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K963413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 2795
• Device Catalogue Number: 2795
• Device Lot Number: 3143T059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown