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

Model Number 2791Q

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product received and evaluated.Product sold in pairs but only one restraint was returned.For the bed connecting strap, the prongs on the male buckle component have broken off and remain engaged with the female component.Close examination of the failed areas appears to show that the breakage does not match, indicating that one end of the male buckle component belongs to another restraint.There is no void found on both ends on the failed areas that would suggest a manufacturing issue contributed to the reported issue.The dhr for this lot of product was reviewed and found no nonconformances or deviations associated with this lot.A sampling of units passed all testing prior to release for shipment.The product ifu was also reviewed and found to provide adequate instructions for the safe and effective use of this device.Possible causes for the malfunction include excessive force or misuse of the device.There does not appear to be a trend for this failure with his device.Upon reviewing the historical complaint there was only one similar complaint received for this part number in 2018.The device was not received for evaluation and the reported issue could therefore not 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.Manufacturer reference file #(b)(4).

Event Description

Customer contacted us via e-mail.No gtin information is available.A ts template has been completed for 2789q and 2791q.Information is limited and we do not have a phone # to contact the customer directly.E-mail was sent along with the rma to ask for additional details, and lot numbers.Customer states that over the weekend that patients broke the plastic clip on the quick release for the 2789q and the 2791q restraints.

• Brand Name: QUICK-RELEASE TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 10870101
• MDR Text Key: 219164257
• Report Number: 2020362-2020-00137
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2020

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: 2791Q
• Device Catalogue Number: 2791Q
• Device Lot Number: 0210T278
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• 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