MAUDE Adverse Event Report: MEXICO QUICK-RELEASE TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number 2789Q

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned.Therefore this report is based solely on customer report.The dhr for lot 1026t021 was reviewed and found that no ncrs were associated with this lot and a sampling of units passed all testing prior to release for shipment.There does not appear to be a trend for this type of failure.There have been 2 other reportable complaints for this part since 2018.Historical complaint data review found one other similar complaint for clips breaking on 2789q.In that instance, the device was returned and evaluated and a void was found in the plastic material of the prong where the break occurred, which may have weakened the prong.Without the return of the device, the reported issue cannot be confirmed.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 warnings 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.(b)(4).

Event Description

Customer reported via email the buckle on the cuff didn't catch.

• Brand Name: QUICK-RELEASE TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEXICO
• Manufacturer Contact: chris rahn ; tidi products llc; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 12225353
• MDR Text Key: 263432201
• Report Number: 2020362-2021-00047
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2021

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 Operator: No Information
• Device Model Number: 2789Q
• Device Catalogue Number: 2789Q
• Device Lot Number: 1026T021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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