MAUDE Adverse Event Report: TIDI PRODUCTS 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  

Manufacturer Narrative

Visual findings observed one pair of restraints received inside the original packaging.One of the single restraints has a male component broken on one of the bed connecting quick release buckles.The broken piece was not returned for evaluation.The other single restraint is intact or appears normal.No void on the broken areas observed.Lint observed on the hook and loop fasteners indicating that the restraints have been washed.All labels are present and legible.Evaluation found that the male component on one of the bed connecting quick release buckles has been damaged.Close examination of the broken areas did not show void material that might suggest that the molding or manufacturing process may have contributed to the reported failure.However, it appeared that the male component may have been damaged/broken when it was not engaged with the female component as the female component appears normal or no physical damages observed.Close examination on the broken piece cannot be done as it was not returned with the restraints for evaluation.Instructions for use state that 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.Discard if device is damaged.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.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 reported via email, the product, broke with the first person they used it on.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 13966375
• MDR Text Key: 288308263
• Report Number: 2020362-2022-00025
• Device Sequence Number: 1
• Product Code: FMQ
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2700Q
• Device Catalogue Number: 2700Q
• Device Lot Number: 1223T036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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