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  

Manufacturer Narrative

Device evaluated by mfr: (b)(4), a territory manager (tm) of tidi products visited the facility after the reported complaint.The product was not returned for evaluation but the tm was able to provide images of the failed product and feedback from customer communications.It was noted that the incident occurred in the behavioral health area in the emergency room where the patient was combative/agitated.The product was first applied to the patient before securing to the bed.Tm advised the customer to attach the product to the bed first making sure that they are not trying to connect the three-point buckle while the patient is pulling and kicking.The images provided revealed that the center prong of a male three point buckle and one of the side prongs are broken.The broken pieces are not in the pictures.Close examination of the broken areas does not reveal any void on the plastic material that would suggest that the issue is related to a manufacturing issue.The possible root cause of this deficiency was that as the patient was pulling and kicking, the customer was trying to connect the male and female buckles even though the buckles were misaligned causing two of the prongs to be damaged.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.Based on the information provided by the tidi territory manager, 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 Description

Customer is reporting a complaints about (b)(4)customer states that while the (b)(4) was in use one of the prongs on the male side of the buckle broke.This allowed the patient to get free of the restraints.There are no reported injuries as a result.Customer has product available to send in.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF, LARGE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr.; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16774027
• MDR Text Key: 313638764
• Report Number: 2182318-2023-00028
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2023

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: 2700QL
• Device Catalogue Number: 2700QL
• Device Lot Number: 2109T042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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